Latest News

Credit: Michael Vi/Shutterstock.com

Boston Scientific has agreed to acquire Penumbra in a deal worth around $14.5bn, a move that will expand the medtech giant’s offerings in ‘fast-growing segments’ within the vascular care space. 

Under the deal, Boston will inherit Penumbra products, including the US company’s Lightning Bolt and Lightning Flash computer-assisted vacuum thrombectomy (CAVT) systems for removing blood clots in the arterial, venous and pulmonary vessels. The systems received US Food and Drug Administration (FDA) clearance in 2023 and 2024, respectively. 

The products will sit alongside AngioJet, the main thrombectomy offering within Boston’s peripheral intervention business. Boston inherited the system following its acquisition of Bayer’s interventional division in 2014. 

The acquisition of Penumbra, which also offers peripheral embolisation and neurovascular solutions, is expected to close in 2026. 

Penumbra’s stock soared by more than 11% at market open following the deal’s announcement on 15 January to $350.80 per share. Penumbra has a market cap of $13.78bn.

Spectrumedics Medical has obtained a CE mark for its coronary intravascular lithotripsy (IVL) system under the European Union’s Medical Device Regulation (EU MDR). 

The Singapore-based company’s Sonico-CX IVL system uses acoustic pressure waves to treat calcified coronary lesions. With the CE mark in hand, Spectrumedics will now focus on commercialising the system in Europe, having previously gained the relevant clearances to initiate commercial rollouts of its system in Latin America and the Asia Pacific (APAC) regions. 

Spectrumedics founder and CEO Dr Elynn Phang said: “This achievement marks a significant step in Spectrumedics’ mission to broaden global access to advanced IVL therapy.  

We look forward to collaborating with more physicians to deliver faster, safer, and more effective treatment to patients with complex calcification worldwide.”

The US Food and Drug Administration (FDA) is moving to relax regulatory requirements for low risk health and wellness wearables, software, and certain other non-medical grade devices.

Outlining the plans during a presentation at the 2026 Consumer Electronics Show (CES), taking place between January 6-9 in Las Vegas, Makary told attendees the FDA needed to move at “the speed of Silicon Valley”, as per a report by ConsumerAffairs.

The exemptions will apply to low risk devices such as heart rate monitors and other wearables that are intended for tracking general healthcare metrics.

In an interview with Fox Business programme Varney & Co, Makary explained: “We want to let companies know, with very clear guidance, that if their device or software is simply providing information, they can do that without FDA regulation.” 

A medtech company CEO believes the J.P. Morgan Healthcare conference’s perceived value is declining.

Speaking to Medical Device Network, Dave Rosa, CEO of NeuroOne, Rosa relayed quotes from attendees at the bustling event. According to Rosa, many people have commented “I don’t think I’m going to come next year” given they no longer “see the value” in attending.

“The meetings that I’ve had here are more of an update, more to say, ‘hey, we’re still interested’, or that it’s ‘good to hear you’re still interested, we’re making great progress’, but not a lot more than that can really be addressed in half an hour,” Rosa said.

Another factor Rosa highlighted may be stymying the appeal of the J.P. Morgan conference is the plain cost associated with attending the event.

A medtech VC firm said kidney care is emerging as a key focus area, citing a range of startups innovating in the space after attending this year’s J.P. Morgan Healthcare Conference. 

Speaking to Medical Device Network after the curtain came down on the conference, which took place between 12-15 January in San Francisco, Shai Policker, co-founder and managing partner at Israeli VC Edge Medical Ventures, said the kidney care space, an area “without too much innovation” in recent times, now appears to be “evolving and waking up”.

“There are now more startups in this field, and in the coming years, I expect more innovation to come, with a focus on the early kidney failure space, the prevention of kidney failure, towards later stage dialysis and kidney replacement and transplants,” Policker said.