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THE TAPE

Medtronic clears a robotic LigaSure vessel sealer for Hugo, nine months after the robot FDA clears Neptune Medical's Triton 1 robotic colonoscope after a 50-patient study FDA takes pathogen-agnostic sequencing to an advisory panel on November 19 CMS adds heart failure and COPD tracks to the ACCESS model, launching spring 2027 FDA posts a Class I recall of Medtronic's Bravo CF delivery device after 184 serious injuries FDA approves Abbott's Aveir VR Mini, 14 percent shorter than the current Aveir VR Mayo Clinic and Thermo Fisher launch Precure to build a million-specimen molecular dataset FDA opens a reliance portal so foreign regulators can lean on its device decisions Medtronic offers a 7 percent discount to push 80.1% of MiniMed onto its own shareholders Medtronic clears a robotic LigaSure vessel sealer for Hugo, nine months after the robot FDA clears Neptune Medical's Triton 1 robotic colonoscope after a 50-patient study FDA takes pathogen-agnostic sequencing to an advisory panel on November 19 CMS adds heart failure and COPD tracks to the ACCESS model, launching spring 2027 FDA posts a Class I recall of Medtronic's Bravo CF delivery device after 184 serious injuries FDA approves Abbott's Aveir VR Mini, 14 percent shorter than the current Aveir VR Mayo Clinic and Thermo Fisher launch Precure to build a million-specimen molecular dataset FDA opens a reliance portal so foreign regulators can lean on its device decisions Medtronic offers a 7 percent discount to push 80.1% of MiniMed onto its own shareholders

Series B

Tandem Health raises $100M with three AI products certified Class IIa under MDR

MedDevice Startups Staff · 3 days ago · 2 min read · Via TNW

Tandem Health raised $100 million in a Series B announced September 14, led by the Scaleup Europe Fund that EQT manages. Kinnevik, Northzone, Amino Collective and Visionaries Club joined. The Stockholm company, founded in 2023, has now raised $160 million, including a $50 million Series A last year.

Three of its products hold Class IIa certification under the EU Medical Device Regulation: the AI scribe, the coding assistant and the clinical decision support tool. Tandem says it reaches 10,000 care organizations in 14 European markets, among them Ramsay Sante, Humanitas and the NHS. It bought Dutch scribe company Juvoly in January.

Most documentation vendors spend their regulatory effort arguing they are not a device. Tandem went the other way and certified under MDR, which costs more at the start and leaves room later to ship a feature that suggests a code or a diagnosis.

Questions & Answers

How much did Tandem Health raise in its Series B?

Tandem Health raised $100 million in a Series B announced September 14, 2026, led by the Scaleup Europe Fund managed by EQT. Kinnevik, Northzone, Amino Collective and Visionaries Club also took part, bringing the Stockholm company's total funding to $160 million.

Are Tandem Health's products regulated as medical devices?

Yes. Three of Tandem Health's products, the AI scribe, the coding assistant and the clinical decision support tool, hold Class IIa certification under the EU Medical Device Regulation.

Where does Tandem Health sell?

Tandem Health says it reaches 10,000 care organizations across 14 European markets, including Ramsay Sante, Humanitas and the NHS. It acquired Dutch AI scribe company Juvoly in January 2026.

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