Boston Scientific Corp.'s Farapoint received U.S. FDA approval for its latest pulsed field ablation catheter. The agency indicated the newest member of the popular Farapulse family for use as an adjunctive device when treating persistent atrial fibrillation that requires cavotricuspid isthmus ablation.

Affluent becoming Carvolix after acquisitions

Affluent Medical SAS is becoming Carvolix after it entered into binding agreements to acquire Caranx Medical SAS for €16.6 million (US$19.34 million) and Artedrone SAS for €11.4 million. The aim is to create an integrated med-tech company which will focus on revolutionizing cardiac valve replacement and stroke treatment through AI-driven autonomous mini-robots and innovative implants.

CDRH withdraws guidance for clinical evaluation of SaMD

The FDA’s Center for Devices and Radiological Health (CDRH) has withdrawn its December 2017 final guidance for clinical evaluation of software as a medical device (SaMD), possibly a move intended to align with the agency’s push toward more modest regulation of digital products. CDRH had copied and pasted a parallel SaMD clinical evaluation document published by the International Medical Device Regulators Forum, but the withdrawal does not by itself seem to signal a full-fledged withdrawal from CDRH’s regulatory harmonization efforts even if some degree of de-harmonization is the practical consequence of these changes.

Top and slop: 2026 is shaping up as another big year for AI

Depending on who you ask, AI will take over the world and save it; or ruin it. Certainly, AI is changing the world. Science magazine dedicated its first editorial of 2026 to AI. Despite its title – “Resisting AI slop“ – editor-in-chief Holden Thorp gave the sort of nuanced review that is typical of him. “Like many tools, AI will allow the scientific community to do more if it picks the right ways to use it,” he wrote. “The community needs to be careful and not be swept up by the hype surrounding every AI product.”

Also in the news

BD, Beyond Air, Boston Scientific, GT Medical Technologies, Iotamotion, Lotte Biologics, Miach Orthopaedics, Precede Biosciences, Rakuten Medical, Rejoni, Tetrascience, Thermo Fisher Scientific, Zap Surgical