JPM25 recap: Robotics, PFA and OTC glucose sensors in the spotlight

CEOs from Medtronic, Intuitive Surgical, Boston Scientific and Dexcom were on hand this week in San Francisco to discuss the year ahead at the J.P. Morgan Healthcare Conference.

By Susan Kelly • Jan. 17, 2025

BD expands syringe, needle production capacity in Nebraska and Connecticut

BD invested $10 million last year to increase manufacturing capacity. The recent expansion has created more than 200 jobs.

By Ricky Zipp • Jan. 17, 2025

Explore the Trendline➔

Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

Tarver warns that US device supply chain vulnerabilities could harm patients

The new director of the FDA’s device center contrasted a European rule with the U.S.’s lack of mandatory reporting requirements for potential device shortages.

By Nick Paul Taylor • Jan. 17, 2025

Hologic receives FDA warning letter over Biozorb implantable markers

Hologic stopped manufacturing the device after reports of serious adverse events in patients who had the markers implanted in breast tissue.

By Elise Reuter • Updated Jan. 16, 2025

Intuitive CEO drills down on da Vinci 5 rollout, force feedback debate

Gary Guthart gave a glimpse of surgeons’ initial response to the new robot at the J.P. Morgan Healthcare Conference.

By Susan Kelly • Jan. 16, 2025

EU mulls retaliation after showing China’s bias against foreign device firms

A report found China limits EU-based device manufacturers’ access to its market through policies that favor local suppliers in an “unfair and discriminatory way.”

By Nick Paul Taylor • Jan. 16, 2025

Dexcom CEO talks Stelo sensor launch, OTC strategy

Kevin Sayer said at the J.P. Morgan Healthcare Conference that Dexcom also expects to release a 15-day glucose sensor in the second half of the year.

By Elise Reuter • Jan. 15, 2025

CMR Surgical makes interim CEO permanent

Massimiliano Colella joined the robot maker as chief commercial officer in 2023 and stepped into the top job when former CEO Supratim Bose resigned late last year.

By Susan Kelly • Jan. 15, 2025

Boston Scientific ups PFA forecast, targets market leadership

At the J.P. Morgan Healthcare Conference, Boston Scientific forecast that pulsed field ablation will be used in more than 60% of atrial fibrillation procedures globally by 2026.

By Nick Paul Taylor • Jan. 15, 2025

Philips recall of heart monitor software tied to 109 injuries, 2 deaths

Some electrocardiogram events, such as atrial fibrillation or abnormally rapid heartbeats, over two years were not reviewed by healthcare professionals due to a data routing issue.

By Ricky Zipp • Jan. 14, 2025

CEO Geoff Martha tells JPM crowd Medtronic is ‘stacking growth drivers’

New technologies for atrial fibrillation, hypertension, diabetes and neurological conditions are poised for fast growth, Martha said Monday at the J.P. Morgan Healthcare Conference.

By Susan Kelly • Jan. 14, 2025

CMS starts Medicare coverage analysis for Medtronic, Recor renal denervation devices

J.P. Morgan analysts said the CMS’ review “validates the technology and could potentially move the needle on growth for Medtronic.”

By Nick Paul Taylor • Jan. 14, 2025

Medtronic inks distribution deal with Contego with option to buy firm

Medtronic will be the exclusive U.S. distributor of Contego Medical’s portfolio, which includes a carotid stent system and thrombectomy devices.

By Ricky Zipp • Jan. 13, 2025

EU medtech regulations reducing options for patients, companies say

Stakeholders branded the MDR and IVDR rules “unreasonably complicated,” “terrible for EU patients and doctors” and “a mess.”

By Nick Paul Taylor • Jan. 13, 2025

Eko Health names Justin Spencer as CFO

Spencer’s arrival at Eko comes months after the digital health company appointed his former colleague Brent Lang to its board of directors.

By Nick Paul Taylor • Jan. 10, 2025

Fire1 raises $120M to trial heart failure management system

Medtronic and Novo Holdings were among the investors in the funding round.

By Nick Paul Taylor • Jan. 10, 2025

Medtronic inks exclusive deal to sell Kuros bone graft device

In the five-year agreement, Medtronic will be the exclusive sales agent for Kuros' product in certain U.S. spine geographies.

By Nick Paul Taylor • Jan. 9, 2025

5 medtech trends to watch in 2025

After a busy 2024, experts called out competition in soft tissue robotics, uncertainty from a Trump White House and continued success for pulsed field ablation as trends to watch this year.

By Ricky Zipp • Jan. 9, 2025

J&J pauses Varipulse PFA cases in US

The temporary halt to investigate reported neurovascular events comes two months after Johnson & Johnson won FDA approval for the pulsed field ablation system.

By Susan Kelly • Jan. 8, 2025

Beta Bionics, maker of ‘bionic pancreas,’ files for IPO

Beta Bionics did not disclose the number of shares it will offer or a price range.

By Elise Reuter • Jan. 8, 2025

Boston Scientific to buy remaining Bolt Medical stake for up to $664M

The deal for Bolt, developer of an intravascular lithotripsy system to treat coronary and peripheral artery disease, continues Boston Scientific’s brisk run of acquisitions.

By Susan Kelly • Jan. 8, 2025

FDA finalizes guidance on device shortage reporting rules

The final version adds information on the devices affected by the guidance and the impact of revised legislation on voluntary notifications.

By Nick Paul Taylor • Jan. 8, 2025

FDA aims to stem AI device bias, boost transparency in draft guidance

The document follows the agency’s first digital health advisory meeting and a final guidance on postmarket updates to AI devices.

By Elise Reuter • Jan. 7, 2025

Outset Medical to pay down debt after raising nearly $300M

Stifel analyst Rick Wise said the financing, a combination of private stock placement and new loans, should help the dialysis device maker return to revenue growth.

By Susan Kelly • Jan. 7, 2025

FDA posts early alert about safety risk of Medline’s fluid delivery sets

The agency issued the alert as part of a pilot to improve the timeliness of communications about actions it believes are likely to be high-risk recalls. 

By Nick Paul Taylor • Jan. 6, 2025