BD recalls emergency vascular access devices over risk of delayed care

Because patients who need intraosseous access are often critically ill, Becton Dickinson warned delays to care caused by the device problems could lead to death.

By Nick Paul Taylor • June 27, 2022

Medtech M&A falls 85% but activity could rebound in second half: report

PwC highlights a range of barriers that could stop acquisitions, including supply chain issues, scrutiny from the Federal Trade Commission and geopolitical concerns.

By Nick Paul Taylor • June 24, 2022

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

Baxter ventilator recall labeled Class I event by FDA after 2 deaths

Baxter initiated the recall after learning that an improper setup could reduce oxygen flow to in-home users, causing serious injury or death.

By Nick Paul Taylor • June 24, 2022

Patient death prompts another recall of Medtronic's HVAD System

The company initiated another recall for the troubled heart pump after a patient died when two batteries simultaneously stopped working, the company said, adding to a list of safety problems with the device.

By Ricky Zipp • June 23, 2022

Bioventus agrees to staggered payment plan to close stalled $315M CartiHeal takeover

Rising interest rates quashed a plan for Bioventus to fund the takeover of the joint repair company with a bond offering. Now, the deal will get much more expensive, J.P. Morgan analysts said.

By Nick Paul Taylor • June 23, 2022

FDA opens consultation on tissue removal devices to reduce cancer risk

The agency is seeking feedback on draft guidance to help manufacturers of tissue containment systems reduce risk that cancerous tissue could leak during procedures.

By Nick Paul Taylor • June 22, 2022

Lack of clinical evidence 'major gap' in digital health: study

The researchers framed the low scores as evidence of “a major gap in health care technology,” adding that there is a “significant opportunity” for companies that differentiate themselves with a more rigorous approach.

By Nick Paul Taylor • June 22, 2022

ZimVie faces challenges in focus on slow-growing, 'highly competitive' spine market: JP Morgan

Still, as a standalone company, the Zimmer spinoff may benefit from tapping higher-growth sub-segments, according to analysts.

By Nick Paul Taylor • June 21, 2022

Senseonics lands CE mark for 6-month CGM implant, teeing up Q3 launch in Europe

Senseonics is looking to the longer-lasting implant to re-energize its fight in a market dominated by Abbott Laboratories and Dexcom.

By Nick Paul Taylor • June 17, 2022

Boston Scientific inks $230M deal to buy majority stake in M.I.Tech

M.I.Tech is a South Korean manufacturer of endoscopic and urologic medical devices. Analysts at BTIG said the deal complements Boston Scientific’s non-vascular stent portfolio and boosts its international presence.

By Nick Paul Taylor • June 16, 2022

Medtronic's Martha says supply chain woes may ease in second half

The CEO told a conference he’s working on plans to revamp pricing as inflation rises and developing a strategy for advancing robotic surgery.

By Nick Paul Taylor • June 16, 2022

User fee package goes to Senate with lab-developed test, OTC hearing aid provisions

The Senate HELP committee passed its version of the FDA user fee bill by a 13-9 vote. It includes an overhaul of diagnostic testing regulations and a requirement to create a category of over-the-counter hearing aids.

By Elise Reuter • June 15, 2022

ResMed to acquire German health software company MediFox for $1B

The acquisition continues a pattern of medical device companies buying software platforms. ResMed expects the deal to close by the end of the year.

By Ricky Zipp • June 14, 2022

Apple Watch monitoring features for AFib, Parkinson's cleared by FDA

With the new feature, atrial fibrillation patients may have an easier way to track the frequency of the condition over time and see whether lifestyle changes may have positive effects.

By Nick Paul Taylor • June 14, 2022

Dräger's breathing system filter recall gets Class I label from FDA after ventilation obstruction

An obstruction in one of the company’s SafeStar 55 devices resulted in a patient being resuscitated after becoming hypoxic.

By Nick Paul Taylor • June 13, 2022

Medical device companies to curb spending as recession threat clouds longer-term outlook: analysts

The supply chain and inflation issues that have affected medical device companies in the first half of 2022 likely will persist through the rest of the year, according to RBC Capital Markets.

By Nick Paul Taylor • June 13, 2022

ResMed warns supply constraints may last 18 months after Philips completes recall of sleep-apnea devices

Analysts at William Blair expect ResMed to achieve “durable market share gains, bordering on permanent” because of Philips’ recall, which affects millions of sleep-apnea and ventilator devices.

By Nick Paul Taylor • June 10, 2022

UnitedHealth links CGM use in people with Type 2 diabetes to improved blood sugar control

J.P. Morgan analysts said they see the results as evidence that continuous glucose monitors have a role to play in support packages for people with Type 2 diabetes.

By Nick Paul Taylor • June 10, 2022

House passes FDA user-fee package, bolstering cybersecurity, clinical trial diversity for medical devices

By a 392-28 vote, the House of Representatives passed its version of the legislation, which would renew the Food and Drug Administration's ability to collect user fees for the next five years.

By Elise Reuter • June 9, 2022

Medtronic: No new patient injury, death reports since April letters warning of HVAD defect

The company’s HeartWare Ventricular Assist Device System received a Class I label from the FDA following two patient injuries and one death.

By Ricky Zipp • Updated June 14, 2022

Insulet targets competitive conversions as Omnipod 5 insulin pump nears full launch

The company said at a conference it aims to increase the rate of insulin pump use among people with Type 1 diabetes in the U.S. 

By Nick Paul Taylor • June 9, 2022

GE Healthcare ventilator battery recall tied to over 1,500 complaints

Ventilators risk shutting down prematurely — cutting the flow of oxygen to patients — as backup batteries may run out of power earlier than expected.

By Nick Paul Taylor • Updated June 28, 2022

FDA mulls pilot program on alternative sterilization for medical devices

The proposed initiative is a response to global supply chain constraints and is intended to support sterilization supply chain resiliency, the agency said. 

By Nick Paul Taylor • June 8, 2022

BD to acquire Parata for $1.53B as part of strategy to boost margins

The deal is expected to help Becton Dickinson reach its goal of a 25% operating margin by the end of 2025. J.P. Morgan analysts said it would be the most meaningful tuck-in deal since BD acquired Bard in 2017. 

By Elise Reuter • June 7, 2022

Dexcom CEO Sayer on G7 FDA submission, developing a 15-day sensor, M&A plans

Kevin Sayer spoke about the company's back-and-forth with the FDA on the G7 CGM system, possibly expanding from a 10-day to a 15-day sensor and on a report that Dexcom was in talks to buy Insulet.

By Ricky Zipp • June 7, 2022