MedDevice Startups

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review

Wed, 02 Sep 2026 13:00:00 GMT

Elucid closed a $55M Series D on September 2, 2026, backed by a fourth public medtech strategic, IAG Capital Partners and Elevage Medical Technologies. Total funding for the Boston company reaches about $185M as its BioIntegrated FFR-CT 510(k) sits under FDA review.

Enovis to buy eCential Robotics for 155 million euros

Tue, 01 Sep 2026 13:00:00 GMT

Enovis signed a binding offer on September 1, 2026 to acquire Grenoble surgical robotics company eCential Robotics for 155 million euros, plus up to 35 million euros in milestone payments. The deal is expected to close at the end of 2026.

FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B

Wed, 19 Aug 2026 16:00:00 GMT

FDA granted De Novo authorization to Vitestro's Aletta on August 19, 2026, the first device that performs a venous blood draw with no hands-on operator. The Utrecht company raised a $70M Series B in March, led by Labcorp Venture Fund, Mayo Clinic and Sutter Health.

Renata Medical raises $25M Series D to scale the Minima pediatric stent

Wed, 19 Aug 2026 12:30:00 GMT

Renata Medical closed a $25M Series D led by ARCHIMED on August 19, 2026. The Newport Beach, CA company's Minima pediatric stent, approved under PMA P240003 in August 2024, gets money for US expansion and international entry.

FDA opens a docket on how to regulate generative AI devices

Tue, 18 Aug 2026 15:00:00 GMT

FDA released the discussion paper Considerations for the Regulation of Generative AI-Enabled Medical Devices on August 18, 2026 under Docket FDA-2026-N-7874, with comments due October 19. It floats a two-axis risk grid, a competency-based assessment modeled on clinician credentialing, and a voluntary master file for foundation models.

FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days

Fri, 14 Aug 2026 12:00:00 GMT

FDA cleared Jupiter Endovascular's Vertex Thrombectomy System (K261523) on August 4, 2026, for removing emboli and thrombi from the pulmonary arteries. The Menlo Park startup filed the traditional 510(k) on May 7, two weeks before presenting its 123-patient SPIRARE II results at EuroPCR.

FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use

Tue, 11 Aug 2026 13:00:00 GMT

FDA cleared Wandercraft's Eve exoskeleton (K260381) on August 3, 2026, for adults with spinal cord injury at any level to walk hands-free at home. The Paris company, which raised a $75M Series D in June 2025 with Renault Group and Bpifrance, plans a U.S. launch on September 17.

Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant

Thu, 06 Aug 2026 13:00:00 GMT

Meduloc closed a $4M Series B led by GenHenn Capital on August 6, 2026. The West Chester, PA company's nitinol Intramedullary Fracture Fixation System, cleared under K250316 in October 2025, enters a controlled alpha launch this month.

FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

Thu, 30 Jul 2026 14:00:00 GMT

FDA published fiscal year 2027 medical device user fee rates on July 30, 2026, effective October 1. The standard 510(k) fee rises to $28,653 and the small business rate to $7,163, while the establishment registration fee climbs to $13,785 with no small business discount.

FDA grants De Novo to Caristo's CaRi-Heart, the first coronary inflammation test read from CT

Wed, 29 Jul 2026 14:00:00 GMT

FDA granted Caristo Diagnostics a De Novo (DEN250042) for CaRi-Heart on July 28, 2026, creating a new class of predictive indicator for long-term cardiovascular outcomes. The Oxford spinout's software quantifies coronary inflammation from routine coronary CT angiography and reports a 10-year cardiac mortality risk.

Aurenar closes $5.7M seed a month after Breakthrough designation for V-Link

Tue, 28 Jul 2026 13:00:00 GMT

Aurenar closed an oversubscribed $5.7M seed round on July 28, 2026, co-led by the AHA's Go Red for Women Venture Fund and Solas BioVentures. Its V-Link ear-worn vagus nerve stimulator for vasospasm after subarachnoid hemorrhage got FDA Breakthrough designation on June 30.

FDA approves Freenome's SimpleScreen CRC blood test, triggering a $100M Abbott payment

Mon, 27 Jul 2026 12:00:00 GMT

FDA granted premarket approval to Freenome's SimpleScreen CRC (P250029) on July 24, 2026, a blood-based colorectal cancer screen for average-risk adults 45 and older. The approval earns Freenome a $100M milestone from Abbott, which holds exclusive U.S. commercial rights, three days after the company began trading on Nasdaq.

Traferox wins PMA for TorEx lung perfusion five years after spinning out of Toronto General

Wed, 22 Jul 2026 13:00:00 GMT

FDA approved Traferox's TorEx Lung Perfusion System (P250025) on July 15, 2026, for ex vivo perfusion of donor lungs initially judged unsuitable for transplant. The Mississauga company was founded in 2021 as a spinout of University Health Network's Toronto General Hospital.

FDA grants De Novo to Claria Medical's contained tissue removal system for hysterectomy

Mon, 13 Jul 2026 13:00:00 GMT

FDA granted Claria Medical a De Novo (DEN250034) on July 2, 2026, for the Claria System, a contained tissue removal device for hysterectomy. The grant-funded Mountain View company reported a median four-minute extraction time for large uteri in its multinational controlled study.

MDUFA VI draft commitment letter would cut the 510(k) average to 112 days by 2032

Wed, 08 Jul 2026 15:00:00 GMT

FDA posted the draft MDUFA VI commitment letter on July 8, 2026, covering fiscal years 2028 through 2032. It steps the average 510(k) total time from 128 days down to 112, adds a 45-day Focused Follow-Up pre-submission, and creates a not grantable letter for De Novo requests.

FDA warning letters put firmware changes and complaint files at the center of two CPAP cases

Tue, 30 Jun 2026 16:00:00 GMT

FDA posted warning letters on June 30, 2026 to BMC Medical and 3B Medical, both dated May 20 and both stemming from a December 2025 inspection. FDA said firmware changes adding new detection algorithms to devices cleared under K153387 required a new 510(k), and that a shipped firmware fix was never reported as a correction.

FDA approves HepQuant's SHUNT liver test, 1,373 days after the PMA was filed

Wed, 24 Jun 2026 13:30:00 GMT

FDA approved HepQuant's SHUNT Liver Diagnostic Test (P220016) on June 18, 2026, to flag compensated cirrhosis patients who can skip a varices screening endoscopy. FDA received the Colorado company's application on September 14, 2022, a 1,373-day review.

FDA closes out the Whoop warning letter over its blood pressure feature

Wed, 17 Jun 2026 18:00:00 GMT

FDA issued a closeout letter to Whoop on June 17, 2026, ending the July 14, 2025 warning letter over Blood Pressure Insights. The agency said it does not intend to enforce device requirements against the modified product, citing changes Whoop made and its own revised general wellness guidance from January 6, 2026.

GT Medical Technologies raises $100M Series E on ROADS data for GammaTile

Tue, 09 Jun 2026 12:30:00 GMT

GT Medical Technologies closed an oversubscribed $100M Series E led by Viking Global Investors on June 9, 2026, bringing total funding to $214M. Its GammaTile brain brachytherapy implant cut 12-month surgical-bed recurrence to 1.3% from 15.4% in the ROADS trial.

FDA approves CyndRx's bioabsorbable AbsorbaSeal closure device after a 931-day PMA review

Fri, 05 Jun 2026 14:00:00 GMT

FDA approved CyndRx's AbsorbaSeal 5.6.7F Vascular Closure Device (P230038) on June 5, 2026, for femoral arterial access sites after procedures using 5F to 7F sheaths. The Brentwood, Tennessee company filed the PMA in November 2023 on the strength of the 220-patient SEAL TO HEAL IDE trial.

CereVasc closes $85M Series C with J&J and Medtronic backing the eShunt trial

Thu, 04 Jun 2026 13:00:00 GMT

CereVasc closed an initial $85M Series C led by Piper Sandler Merchant Banking on June 4, 2026, with J&J's JJDC and Medtronic both investing. The Boston company is running the STRIDE trial of eShunt, an endovascular CSF shunt for normal pressure hydrocephalus.

Veritas Aortic Solutions raises $12M seed for a transcatheter aortic root conduit

Mon, 01 Jun 2026 13:01:00 GMT

Veritas Aortic Solutions, an inQB8 Medical Technologies spinout in Costa Mesa, CA, closed a $12M seed round on June 1, 2026. Medtech angel investors led, with Cedars-Sinai Intellectual Property Company joining, to take the TVARC aortic root implant to first-in-human use.

Resmed closes $340M purchase of Noctrix Health

Mon, 01 Jun 2026 13:00:00 GMT

Resmed completed its $340 million acquisition of Noctrix Health on June 1, 2026. Noctrix makes Nidra, a wearable nerve stimulation device for restless legs syndrome that FDA authorized through De Novo DEN220059 in 2023.

FDA finalizes human factors guidance and sorts every submission into one of three categories

Fri, 29 May 2026 14:00:00 GMT

FDA issued the final guidance Content of Human Factors Information in Medical Device Marketing Submissions on May 29, 2026, finalizing a December 2022 draft. It assigns each submission to one of three HF categories, and eSTAR added a matching drop-down effective August 1, 2026.

FDA grants De Novo to Cardiosense for wearable software that estimates wedge pressure

Wed, 27 May 2026 12:00:00 GMT

FDA granted Cardiosense a De Novo (DEN250057) on May 22, 2026, for software that estimates wedge pressure from its chest-worn CardioTag sensor in HFrEF patients. The Chicago company cleared the sensor itself under a 510(k) in July 2025.

MedTech Innovator picks 65 startups from 1,835 applicants

Wed, 27 May 2026 11:00:00 GMT

MedTech Innovator named 65 companies to its 2026 accelerator cohort on May 27, 2026, drawn from 1,835 applicants. The cohort competes for $800,000 in non-dilutive prizes across finals in Boston in October and San Diego in November.

Boston Scientific puts $1.5B into MiRus for a 34% stake and a TAVR option

Mon, 18 May 2026 12:00:00 GMT

Boston Scientific announced a $1.5B investment in MiRus on May 18, 2026, buying about 34% of the company. It also holds an option on the rest of MiRus's TAVR business, whose nickel-free SIEGEL valve has entered a 1,025-patient approval trial.

Stryker pays up to $835M for Amplitude Vascular Systems

Mon, 11 May 2026 13:00:00 GMT

Stryker agreed on April 13, 2026 to acquire Amplitude Vascular Systems, then disclosed in a May 11 SEC filing that the deal is worth up to $835 million: about $435 million in cash plus up to $400 million in milestones. The Waltham company's Pulse IVL system is still investigational.

MHRA publishes draft 2026 device regulations with a reliance route for FDA-cleared products

Mon, 11 May 2026 09:00:00 GMT

MHRA published the draft Medical Devices (Amendment) Regulations 2026 and opened a stakeholder impact survey on May 11, 2026, closing June 19. The draft creates an international reliance route recognising approvals from Australia, Canada and the United States, and adds a predetermined change control plan pathway for software.

Mobia Medical prices $150M Nasdaq IPO for the Vivistim stroke implant

Thu, 07 May 2026 22:10:00 GMT

Mobia Medical, the renamed MicroTransponder, priced its IPO at $15 a share on May 7, 2026, selling 10 million shares for $150M gross. Its Vivistim stroke implant, approved under PMA P210007 in 2021, brought in $32M of revenue in 2025.

Aidoc raises $150M Series E led by Goldman Sachs for its CARE foundation model

Wed, 29 Apr 2026 15:00:00 GMT

Aidoc announced a $150M Series E led by Growth Equity at Goldman Sachs Alternatives on April 29, 2026, taking total funding past $500M. The radiology AI company runs in nearly 2,000 hospitals and holds more than 30 FDA 510(k) clearances.

Axoft raises $55M Series A for soft-material brain implants

Wed, 29 Apr 2026 13:00:00 GMT

Axoft closed an oversubscribed $55M Series A led by C.P. Group Innovation on April 29, 2026. The Cambridge, MA company has implanted its Fleuron-based brain-computer interface in 11 or more patients and will build a GMP plant in Boston.

Hypervision Surgical raises £17M Series A for FDA-cleared hyperspectral surgical imaging

Wed, 29 Apr 2026 09:00:00 GMT

Hypervision Surgical closed a £17M (about $23M) Series A led by Heal Capital on April 29, 2026. Its HyperSnap Surgical System was cleared under K250268 in June 2025 with a new product code for AI-based video augmentation in surgery.

J&J MedTech to buy Atraverse Medical and its Hotwire guidewire

Mon, 27 Apr 2026 15:00:00 GMT

Johnson & Johnson agreed on April 27, 2026 to acquire Atraverse Medical, the Cardiff by the Sea company behind the Hotwire radiofrequency guidewire for left-heart access. Terms were not disclosed and the deal was expected to close in the second quarter of 2026.

CMS and FDA propose same-day coverage decisions for breakthrough devices

Thu, 23 Apr 2026 15:00:00 GMT

CMS and FDA announced the RAPID coverage pathway on April 23, 2026. CMS would issue a proposed national coverage determination on the day FDA grants marketing authorization, putting Medicare coverage roughly two months out instead of a year or more. About 40 devices qualify today.

Sight Diagnostics lays off its remaining staff after $124M raised

Tue, 21 Apr 2026 09:00:00 GMT

Sight Diagnostics dismissed its roughly 20 remaining employees in April 2026, ending a 15-year run that raised about $124 million. Its OLO blood count analyzer had FDA clearance under K190898 and K211840.

E2 raises $80M Series C to sell the Hēlo thrombectomy catheter cleared under K252956

Tue, 07 Apr 2026 13:00:00 GMT

Endovascular Engineering (E2) closed an oversubscribed $80M Series C co-led by Gilde Healthcare and Norwest on April 7, 2026. The Menlo Park company will build a sales force for Hēlo, its thrombectomy catheter cleared under K252956 in December 2025.

FDA approves Endospan's NEXUS aortic arch stent graft, starting Artivion's 90-day buyout clock

Tue, 07 Apr 2026 12:00:00 GMT

FDA approved Endospan's NEXUS Aortic Arch Stent Graft System (P250033) on April 2, 2026, for chronic dissections involving the aortic arch in high-risk surgical patients. Artivion, which distributes NEXUS in Europe, now has 90 days to exercise an option to buy the 50-person Israeli company.

Endogenex adds $50M Series C extension to finish the ReCET diabetes study

Wed, 25 Mar 2026 12:00:00 GMT

Endogenex closed a $50M Series C extension on March 25, 2026, led by new investor Arboretum Ventures. The Series C now totals $138M and funds the sham-controlled study of ReCET, its endoscopic pulsed electric field therapy for type 2 diabetes.

FDA approves JenaValve's Trilogy valve, the first TAVR for aortic regurgitation

Wed, 18 Mar 2026 13:00:00 GMT

FDA approved JenaValve Technology's Trilogy Transcatheter Heart Valve System (P250024) on March 17, 2026, for symptomatic, severe aortic regurgitation in patients at high surgical risk. The decision came two months after a federal judge blocked Edwards Lifesciences' $1.2B bid for the Irvine company.

FDA clears Perfuze's Millipede88 as the first super-bore catheter for standalone stroke aspiration

Tue, 17 Mar 2026 13:00:00 GMT

FDA cleared Perfuze's Millipede System (K253590) on March 16, 2026, making the 0.088-inch Millipede88 the first super-bore catheter indicated for standalone direct aspiration in stroke. The Galway company backed the filing with the 180-patient MARRS study and had raised €22M from existing investors a year earlier.

Vitestro raises $70M Series B to take the Aletta blood-draw robot through De Novo

Tue, 10 Mar 2026 14:00:00 GMT

Vitestro closed an oversubscribed $70M Series B on March 10, 2026, with Labcorp Venture Fund, Mayo Clinic and Sutter Health among new investors. The Utrecht company will use it for a De Novo submission and US scale-up of Aletta, its autonomous blood-draw robot.

Cognito Therapeutics closes $105M Series C ahead of Spectris HOPE readout

Thu, 05 Mar 2026 13:30:00 GMT

Cognito Therapeutics closed an oversubscribed $105M Series C on March 5, 2026, co-led by Morningside Ventures, IAG Capital Partners and Starbloom Capital. The money carries its Spectris gamma stimulation device for Alzheimer's through HOPE trial data, an FDA submission and a 2027 launch.

Perimeter wins PMA for Claire, the first AI-enabled imaging device for breast cancer surgery

Tue, 03 Mar 2026 13:00:00 GMT

FDA approved Perimeter Medical Imaging AI's Claire OCT System (P250008) on March 3, 2026, for margin assessment of excised lumpectomy tissue during surgery. The Toronto company, listed on the TSX Venture Exchange, reported 88.1% margin accuracy in a trial funded by a $7.4M CPRIT grant.

Synergy Spine's cervical disc wins PMA in 210 days

Fri, 27 Feb 2026 14:00:00 GMT

FDA approved the Synergy Disc on February 26, 2026 under P250028, 210 days after Synergy Spine Solutions filed the PMA. The Louisville, Colorado company's single-level cervical disc beat ACDF fusion on composite clinical success, 87.1% with p<0.0001, in its IDE trial.

Allurion's swallowable balloon wins PMA after a split on co-primary endpoints

Mon, 23 Feb 2026 13:00:00 GMT

FDA approved the Allurion Gastric Balloon System on February 20, 2026 under P250023. The label covers adults 22 to 65 with a BMI of 30 to 40. In the 550-patient AUDACITY trial the responder co-primary endpoint passed while the comparative endpoint missed its 3% superiority margin.

Empirical Spine's LimiFlex tether wins PMA 38 months after filing

Wed, 18 Feb 2026 14:00:00 GMT

FDA approved Empirical Spine's LimiFlex Dynamic Sagittal Tether on February 12, 2026 under P220031, a PMA received December 19, 2022. The motion-preserving alternative to fusion for Grade I degenerative spondylolisthesis held Breakthrough designation since April 2021 and was tested against 160 TLIF patients.

Neurent Medical raises 62.5M euro Series C to scale NEUROMARK for chronic rhinitis

Wed, 11 Feb 2026 15:00:00 GMT

Neurent Medical closed an oversubscribed 62.5 million euro ($74 million) Series C on February 11, 2026. MVM Partners led, with Sofinnova Partners joining as a new investor. The Galway company's NEUROMARK radiofrequency system has held 510(k) clearance since October 2021.

QMSR takes effect: what changed for a startup's quality system on February 2

Mon, 02 Feb 2026 14:00:00 GMT

The Quality Management System Regulation replaced the Quality System Regulation in 21 CFR Part 820 on February 2, 2026, incorporating ISO 13485:2016 by reference. FDA retired QSIT the same day and began inspecting against compliance program 7382.850, which opens management review, internal audit and supplier audit records to investigators.

Inquis Medical raises $75M Series C from an unnamed strategic for Aventus thrombectomy

Mon, 12 Jan 2026 16:00:00 GMT

Inquis Medical closed a $75 million Series C on January 12, 2026, funded by an undisclosed strategic investor. The Menlo Park company's Aventus thrombectomy system has a string of 510(k)s, including the June 2025 pulmonary embolism clearance under K251189.

Neurolief's ProlivRx wins PMA, triggering BrainsWay's next $6M tranche

Mon, 12 Jan 2026 13:00:00 GMT

FDA approved Neurolief's ProlivRx headset on December 31, 2025 under P250010. The label is adjunctive at-home treatment for major depressive disorder in adults who failed at least one antidepressant. The approval trips a milestone in BrainsWay's August 2025 deal, which committed up to $6 million more on FDA approval.

Ventaris Surgical raises $30M Series A for a ureteroscope built for complete stone clearance

Fri, 09 Jan 2026 17:00:00 GMT

Ventaris Surgical closed a $30 million Series A led by Longitude Capital on January 9, 2026, with Vensana Capital joining as a new investor. The San Carlos company is developing a ureteroscopic system aimed at complete kidney stone clearance in a single procedure.

Spiro Medical raises $67M Series A for an implantable asthma neuromodulator

Wed, 07 Jan 2026 13:00:00 GMT

Spiro Medical closed a $67 million Series A led by Andera Partners on January 7, 2026, with Omega Funds and Sherpa Healthcare Partners co-leading. The Irvine startup, which surfaced in 2025, is developing a Pulmonary Neuromodulation System for severe asthma.

FDA rewrites the clinical decision support and general wellness guidances without a draft

Tue, 06 Jan 2026 17:00:00 GMT

On January 6, 2026 FDA issued revised final versions of its Clinical Decision Support Software and General Wellness guidances, skipping the usual comment period. Software giving a single clinically appropriate recommendation can now fall outside device oversight, and wearables estimating blood pressure, oxygen saturation or glucose can be sold as wellness products.

HAI Solutions' QIKCAP De Novo creates a new UVC device class for IV connectors

Tue, 30 Dec 2025 14:00:00 GMT

FDA granted HAI Solutions' De Novo request for the QIKCAP System on December 23, 2025. The grant creates a new Class II regulation, 21 CFR 880.6512, for UVC microbial reduction devices for luer-activated valves. The Carlsbad startup announced DEN250004 on December 30 after a 327-day review.

Biobeat raises $50M Series B for its cuffless 24-hour blood pressure patch

Tue, 30 Dec 2025 13:00:00 GMT

Biobeat Technologies closed a $50 million Series B co-led by Ally Bridge Group, OrbiMed and Elevage Medical on December 30, 2025. The Israeli company's chest patch, cleared under K241066 in January 2025, measures ambulatory blood pressure without a cuff.

FDA clears UpDoc's conversational insulin dosing software in 85 days

Tue, 23 Dec 2025 18:00:00 GMT

FDA cleared UpDoc on December 23, 2025 under K253281, 85 days after the Mountain View startup filed. The prescription software takes glucose, meal and symptom data through a voice or chat agent and issues insulin instructions from prescriber-set parameters. The 510(k) summary reports no clinical testing.

European Commission proposes dropping the five-year certificate limit and reclassifying software under MDR

Tue, 16 Dec 2025 12:00:00 GMT

The Commission adopted COM(2025) 1023 on December 16, 2025, a targeted revision of the MDR and IVDR. It would remove maximum certificate validity, move some software and reusable instruments to lower classes, cut notified body fees for micro and small manufacturers, and create designated pathways for orphan and breakthrough devices. The Commission estimates savings above 3 billion euros a year.

Zenflow's Spring implant wins PMA two days after rival ProVerum

Thu, 11 Dec 2025 21:40:00 GMT

FDA approved Zenflow's Spring Implant and Delivery System for BPH on December 11, 2025 under P250007, a 275-day review. In the BREEZE trial of more than 200 men, 60% of treated patients were responders at one year versus 33% on sham.

Flow Neuroscience wins the first PMA for an at-home depression headset

Thu, 11 Dec 2025 16:00:00 GMT

FDA approved Flow Neuroscience's FL-100 tDCS headset on December 8, 2025 under P230024. It is the first prescription at-home brain stimulation device for major depressive disorder in the US. The Malmö startup filed in August 2023 and backed the PMA with a 174-patient sham-controlled trial.

ProVerum's ProVee stent wins PMA 106 days after an $80M Series B

Tue, 09 Dec 2025 14:00:00 GMT

FDA approved ProVerum's ProVee System for BPH on December 9, 2025 under P250011, a 251-day review. The Dublin company closed an $80 million Series B led by MVM Partners on August 25 to fund the US launch.

FDA's TEMPO pilot lets unauthorized digital health devices reach Medicare patients

Mon, 08 Dec 2025 15:00:00 GMT

FDA published the Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot in the Federal Register on December 8, 2025 under Docket FDA-2025-N-6461. Up to about ten U.S. manufacturers per clinical area can offer digital health devices to CMS ACCESS model participants without premarket authorization, in exchange for real-world data and a plan to seek clearance.

Four EUDAMED modules become mandatory on May 28, 2026

Tue, 02 Dec 2025 10:00:00 GMT

Commission Decision (EU) 2025/2371, published in the Official Journal on November 27, 2025, confirmed that the actor registration, UDI and device registration, notified bodies and certificates, and market surveillance modules of EUDAMED become mandatory on May 28, 2026. Devices already on the market have until November 27, 2026 to complete UDI registration.

Akura Medical closes $53M Series C first close led by Qatar Investment Authority

Mon, 01 Dec 2025 14:00:00 GMT

Akura Medical closed the first $53 million of a Series C led by the Qatar Investment Authority on December 1, 2025. The Shifamed portfolio company will finish enrolling the QUADRA-PE trial of its Katana thrombectomy system and set up a joint venture in Qatar.

FDA approves Cleveland Diagnostics' IsoPSA PMA nearly five years after filing

Mon, 01 Dec 2025 14:00:00 GMT

FDA approved Cleveland Diagnostics' IsoPSA blood test on November 28, 2025 under P200048, a PMA the agency received on December 28, 2020. The test is indicated for men 50 and older with PSA between 4.0 and 10.0 ng/mL who are being considered for biopsy.

Cordance Medical raises $8M seed for focused ultrasound that opens the blood-brain barrier

Mon, 24 Nov 2025 14:00:00 GMT

Cordance Medical closed an oversubscribed seed round of more than $8 million led by Sonder Capital, announced November 24, 2025. The Mountain View company holds an FDA Breakthrough Device designation in neuro-oncology and is planning its first-in-human trial.

Okami Medical raises $45M and hires former Inari CEO Drew Hykes

Wed, 19 Nov 2025 13:00:00 GMT

Okami Medical closed a $45 million financing led by new investor Gilde Healthcare on November 19, 2025, with Vensana Capital and U.S. Venture Partners returning. The Aliso Viejo company also named former Inari Medical CEO Drew Hykes president and CEO.

Distalmotion raises $150M Series G to push the Dexter robot into ASCs

Tue, 18 Nov 2025 13:00:00 GMT

Distalmotion closed a $150 million Series G led by Revival Healthcare Capital on November 18, 2025. The Lausanne company also named former Silk Road Medical CEO Chas McKhann executive chairman as it targets U.S. ambulatory surgery centers with the Dexter robot.

FDA resumes accepting 510(k)s and De Novos after a 43-day shutdown

Thu, 13 Nov 2025 14:00:00 GMT

The federal shutdown that began October 1, 2025 ended November 12 after 43 days, the longest on record. During the lapse FDA could not accept new device submissions requiring a user fee, while reviews already paid for continued on MDUFA carryover balances.

Beacon Biosignals raises $86M Series B for its FDA-cleared EEG headband

Thu, 13 Nov 2025 11:30:00 GMT

Beacon Biosignals closed an oversubscribed $86 million Series B on November 13, 2025, with six co-leads including Innoviva, GV and Takeda. The Boston company's Waveband headband, formerly Dreem 3S, holds three 510(k)s.

Synchron raises $200M Series D to take the Stentrode BCI into late-stage trials

Thu, 06 Nov 2025 13:00:00 GMT

Synchron closed a $200 million Series D led by Double Point Ventures on November 6, 2025, bringing total funding to $345 million. The New York company will use it for late-stage trials and launch preparation for the Stentrode endovascular brain-computer interface.

Pulsenmore wins De Novo for home prenatal ultrasound after 324-day review

Mon, 03 Nov 2025 13:00:00 GMT

FDA granted Pulsenmore's De Novo request for the Pulsenmore ES home prenatal ultrasound on October 31, 2025, creating a new device type under DEN240074. The Israeli company's shares rose 33% on the Tel Aviv Stock Exchange when it announced the grant on November 3.

Tulyp Medical leaves stealth with a 510(k) filed for its perfusion system

Mon, 03 Nov 2025 07:00:00 GMT

Tulyp Medical came out of stealth on November 3, 2025, announcing an FDA 510(k) submission for a pressure-driven perfusion system after a first-in-human leg artery bypass case. The Paris company was built inside Sofinnova's MD Start accelerator.

FDA drafts an ISO 13485-shaped quality system section for PMA and HDE submissions

Mon, 27 Oct 2025 16:00:00 GMT

FDA issued the draft guidance Quality Management System Information for Certain Premarket Submission Reviews on October 27, 2025 under Docket FDA-2025-D-4051. It replaces a 2003 document and rebuilds what PMA and HDE applicants file around the QMSR taking effect February 2, 2026.

CoMind raises $60M Series A, taking total funding to $102.5M

Mon, 20 Oct 2025 08:00:00 GMT

London neurotech CoMind announced $102.5 million in total funding on October 20, 2025, with the new $60 million Series A led by Plural. The money goes to U.S. regulatory work on CoMind One, a non-invasive bedside brain monitor.

HistoSonics raises $250M two months after its $2.25B buyout

Thu, 16 Oct 2025 14:00:00 GMT

HistoSonics closed an oversubscribed $250 million growth financing on October 16, 2025. Its new ownership group led, two months after buying a majority stake at a $2.25 billion valuation.

Chiesi pays Samay to build small airway disease detection into Sylvee

Thu, 09 Oct 2025 13:00:00 GMT

Samay agreed to develop small airway disease algorithms for its Sylvee wearable chest sensor under a paid deal with Italian drugmaker Chiesi, reported October 9, 2025. Chiesi funds the model work and a pilot study, with results expected by April 2026, and takes no equity.

Armor Medical wins MedTech Innovator's $350K grand prize

Wed, 08 Oct 2025 18:00:00 GMT

Armor Medical won MedTech Innovator's 2025 grand prize and $350,000 in non-dilutive funding on October 8, 2025, at The MedTech Conference in San Diego. The Atlanta company is developing a wrist-worn monitor that detects postpartum hemorrhage.

Bunkerhill Health lands seventh 510(k) with first AI for mitral annular calcification

Wed, 08 Oct 2025 15:00:00 GMT

FDA cleared Bunkerhill MAC on October 3, 2025 under K250662. It is the first AI algorithm cleared to detect and quantify mitral annular calcification on routine non-gated chest CT. It is the San Francisco company's seventh 510(k) since April 2023 and its second in 14 days.

Jupiter Endovascular closes Series B above $40M a month after Vertex clearance

Tue, 07 Oct 2025 12:00:00 GMT

Jupiter Endovascular closed an oversubscribed Series B above its $40 million target on October 7, 2025, led by Sonder Capital. FDA cleared the company's Vertex catheter under K252027 on September 12, 74 days after receipt.

eSTAR becomes mandatory for De Novo requests on October 1

Wed, 01 Oct 2025 13:00:00 GMT

From October 1, 2025, FDA accepts De Novo classification requests only as eSTAR submissions sent through the CDRH Portal. The requirement was set in an August 2024 final guidance and follows the October 2023 eSTAR mandate for 510(k)s.

Kardium runs first commercial Globe PFA cases in Arkansas

Wed, 01 Oct 2025 13:00:00 GMT

Kardium reported its first commercial cases with the Globe Pulsed Field System on October 1, 2025, at St. Bernard's Medical Center in Jonesboro, Arkansas. FDA approved the system under P240044 on August 27, 2025.

FDA finalizes computer software assurance guidance and retires Section 6 of the 2002 validation rules

Wed, 24 Sep 2025 15:00:00 GMT

FDA issued the final guidance Computer Software Assurance for Production and Quality System Software on September 24, 2025, three years after the draft. It supersedes Section 6 of the 2002 General Principles of Software Validation and scales assurance work to the risk each software tool carries.

FDA strikes the LDT rule from the CFR after losing in court

Fri, 19 Sep 2025 16:00:00 GMT

FDA published a final rule on September 19, 2025 removing the laboratory developed test language it added to 21 CFR 809.3 in May 2024. The action implements the March 31, 2025 vacatur by a federal court in Texas, a decision FDA chose not to appeal.

Jupiter Endovascular's Vertex catheter clears 510(k) in 74 days

Wed, 17 Sep 2025 14:00:00 GMT

FDA cleared Jupiter Endovascular's Vertex catheter on September 12, 2025 under K252027, 74 days after the June 30 submission. The clearance covers insertion of endovascular devices; the pulmonary embolism claim still depends on the SPIRARE II trial.

FDA approves Womed Leaf, the first device for Asherman syndrome, under P240015

Tue, 16 Sep 2025 13:00:00 GMT

FDA approved Womed's Leaf resorbable adhesion barrier on September 9, 2025 under P240015, the first US device for moderate to severe intrauterine adhesions. The Montpellier startup filed in May 2024 and backed the PMA with a 160-patient trial.

Ronovo Surgical raises $67M Series D led by J&J's venture arm

Fri, 05 Sep 2025 13:00:00 GMT

Shanghai-based Ronovo Surgical closed a $67 million Series D led by JJDC, Johnson & Johnson's venture arm, announced September 5, 2025. The round came with a commercial agreement with J&J MedTech in China for the Carina laparoscopic robot.

Galvanize Therapeutics raises $100M Series C for pulsed electric field ablation

Wed, 03 Sep 2025 12:00:00 GMT

Galvanize Therapeutics closed an oversubscribed $100 million Series C led by Sofinnova Partners on September 3, 2025. The Redwood City company also named former Shockwave CEO Doug Godshall as chairman and CEO.