Getinge recalls anesthesia machines due to cracked, broken suction power switches

The FDA labeled the recall a Class I event, marking Getinge’s fifth Class I recall since September.

By Ricky Zipp • July 7, 2022

Intuitive's ecosystem is making it harder for J&J, Medtronic to crack robotic surgery market, say analysts

Intuitive’s competitors will need an “ecosystem approach” that goes beyond hardware to make it easier for customers to switch, say analysts from BTIG.

By Nick Paul Taylor • July 7, 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

Wearables are a growing part of doctor-patient talks for cardiac patients: study

As mentions of wearables in primary care grew, Apple increasingly replaced Fitbit as the most-discussed wearable brand in talks between physicians and patients in the study, which covered the years 2005 to 2019. 

By Nick Paul Taylor • July 6, 2022

Senators press FDA to finalize OTC hearing aids, accuse industry of 'astroturf' campaigns

The two cross-aisle politicians said they want to “expand access, reduce costs, and ensure a robust new market for safe and effective OTC hearing aids” and accused the device manufacturing lobby of “harming American consumers.”

By Elise Reuter • July 6, 2022

'Little sign' that digital tools are being deployed effectively in fight against COVID outbreak, study finds

To help reduce the spread of the next pandemic, there is “a substantial practical advantage” to integrating the features of multiple smartphone apps, a Scripps Research Translational Institute team found.

By Nick Paul Taylor • July 6, 2022

American Contract Systems' COVID-19 test recall gets Class I label from FDA

Off-site assembly by workers who may not have been properly trained prompted the company to recall COVID-19 tests amid concerns they may yield false results. 

By Nick Paul Taylor • Updated July 6, 2022

AliveCor ECG patent ruling sets stage for block on Apple Watch imports

Apple Watch imports to the U.S. could be barred if ruling by International Trade Court judge is finalized; Judge says Apple Watch infringes two cardiogram patents.

By Nick Paul Taylor • July 5, 2022

Friday Q&A: Canary Medical CEO Bill Hunter discusses knee-implant sensors, device reimbursement

Canary’s founder discusses how the firm plans to create predictive tools from data collected by the devices, and long-term plans to embed its sensors in other implants.

By Elise Reuter • July 1, 2022

LiveMetric's blood-pressure 'smartwatch' device gets FDA clearance

The wristwatch-like device will be made available through health systems, insurers and self-insured employers to ease continuous monitoring of blood pressure and avoid white-coat syndrome.

By Nick Paul Taylor • July 1, 2022

Intuitive secures FDA clearance for lung biopsy robot featuring Siemens' imaging tech

The FDA clearance is an “incremental positive” for Intuitive, wrote analysts at RBC Capital Markets, adding that they see Ion as “an important leg of growth for the company.”

By Nick Paul Taylor • July 1, 2022

As Philips works to replace or repair recalled devices, supply problems are slowing it down

Logistical challenges mean patients won’t know when they will get a replacement sleep apnea or ventilator device until “at best a few weeks before it is delivered,” Philips executives said.

By Ricky Zipp • June 30, 2022

GE Healthcare powers Cleveland Clinic imaging spinout to $33M financing round

Centerline will use the funding to expand into Europe and other international markets next year, as well as to advance the use of its technology in new surgical applications.

By Nick Paul Taylor • June 30, 2022

Eargo reaches financing deal as it looks to regain insurance coverage after DOJ settlement

A $125 million financing deal puts pressure on the hearing aid maker to make a quick turnaround as it works to win back its largest customer, the Federal Employee Health Benefits Program.

By Elise Reuter • June 29, 2022

Companies see a future for smart implants. Doctors are waiting for proof.

Zimmer Biomet and Canary Medical are rolling out the first knee implant with an integrated sensor, though it will take time to learn how to incorporate that data into patient care, experts say.

By Elise Reuter • June 28, 2022

Sleep apnea devices show 'very low' amount of degraded foam, Philips says

Philips found evidence of foam breaking down in about 2% of 60,847 returned first generation DreamStation devices. The company said the problem was more prevalent in devices that used an ozone cleaning method. 

By Ricky Zipp • June 28, 2022

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

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