Integra receives warning letter related to quality issues at Boston plant

The company recalled all products made at its Boston facility over the last five years, and hopes to restart manufacturing in the fourth quarter.

By Elise Reuter • Updated Aug. 17, 2023

One death, 2 injuries reported in recall of Philips Trilogy ventilators

Philips warned in a previous recall about problems with the devices’ sensors that can lead to under-delivery of oxygen.

By Elise Reuter • Aug. 16, 2023

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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

GE HealthCare wins FDA clearance for wireless hospital vital sign monitor

The Portrait Mobile device is one of GE HealthCare’s “first major introductions in monitoring in recent years,” according to the company.

By Nick Paul Taylor • Aug. 16, 2023

Medtronic’s dialysis device recall assigned to Class I by the FDA

The company contacted customers after routine manufacturing testing identified a blockage that could obstruct the catheter.

By Nick Paul Taylor • Aug. 16, 2023

Insulet claims EOFlow copied patch-pump design in patent suit

Insulet filed the lawsuit as competitor Medtronic plans to buy EOFlow for $738 million.

By Elise Reuter • Aug. 15, 2023

Medtronic’s bid to dismiss heart device kickback claims fails, clearing case to advance

A whistleblower accused Medtronic of violating the False Claims Act by billing the government for unnecessary medical procedures.

By Nick Paul Taylor • Updated Aug. 15, 2023

Boston Scientific’s pivotal pulsed field ablation trial expected to succeed: analysts

Positive results could position Boston Scientific to win U.S. approval for Farapulse in the second half of next year.

By Nick Paul Taylor • Aug. 14, 2023

Senseonics seeks iCGM designation for implantable glucose monitor

The company also plans to submit results of a pivotal trial for a version of its device that can be worn for a year.

By Elise Reuter • Aug. 11, 2023

Median lag between FDA authorization and Medicare coverage hits 6 years: study

Fewer than 30% of novel medical devices obtain some Medicare coverage in the three years after regulatory authorization, researchers found.

By Nick Paul Taylor • Aug. 11, 2023

Getinge’s heart assist pump shutdown problem given FDA Class I recall tag

The company notified healthcare providers after receiving 26 complaints about Cardiosave devices, used to support severely ill patients, unexpectedly shutting down.

By Nick Paul Taylor • Aug. 11, 2023

Boston Scientific receives FDA approval for cryoablation system

The company hopes to build on interest in Europe and Japan as competitors bring new cardiac ablation devices to market.

By Elise Reuter • Aug. 10, 2023

ZimVie wins FDA approval for smaller Mobi-C cervical disc

The device maker said the new product will “address the anatomical needs of the U.S. patient population.”

By Nick Paul Taylor • Aug. 10, 2023

Stryker touts Mako robot in DTC ads, as device makers eye broader patient populations

The company is taking its message on the benefits of robotic orthopedic surgery directly to patients at a time when analysts say medtech firms are targeting a wider audience through advertising.

By Susan Kelly • Aug. 9, 2023

Device volumes to hold up against threat of Wegovy, other GLP-1 drugs: analysts

Issues such as “nontrivial side effects, cost concerns and patient persistence” will mean physicians continue to use medical devices, analysts say.

By Nick Paul Taylor • Aug. 9, 2023

Elon Musk’s brain implant company raises $280M to fund clinical trials

Peter Thiel's venture capital firm led the investment weeks after Neuralink secured clearance to study its device in humans.

By Nick Paul Taylor • Aug. 9, 2023

Guardant, Illumina agree to end litigation, extend commercial partnership

The two sides will now renew a long-term collaboration to advance cancer research, Guardant said.

By Susan Kelly • Aug. 8, 2023

Abbott lands FDA clearance of Alinity complete blood count system

The company claims the device uses less floor space and has one of the highest throughputs as it competes with diagnostic systems made by Beckman Coulter and Siemens Healthineers.

By Nick Paul Taylor • Aug. 8, 2023

Appeals court overturns ruling in Axonics-Medtronic neurostim patent dispute

The court said the patent board’s “refusal to consider the new arguments and evidence was erroneous.” 

By Nick Paul Taylor • Aug. 8, 2023

J&J subsidiary gains approval for heart ablation devices to use without fluoroscopy

The expanded label could limit exposure to radiation while patients are treated for heart arrhythmias.

By Elise Reuter • Aug. 7, 2023

Medtronic expected to prevail at FDA renal denervation vote despite data doubts: analysts

Needham analysts predict the experts will vote in favor of Medtronic and put the device on track to target a $1 billion-plus market.

By Nick Paul Taylor • Aug. 7, 2023

Anne-Françoise Nesmes to step down as Smith+Nephew CFO next year

The announcement comes as Smith+Nephew raised its forecast for the year to a 6% to 7% revenue increase, due to more favorable market conditions. 

By Nick Paul Taylor • Aug. 7, 2023

Stryker raises earnings forecast as procedures return to pre-pandemic levels

The company expects elevated procedure demand to continue into 2024 due to surgery backlogs.

By Elise Reuter • Aug. 4, 2023

Q&A: How Monogram’s CEO plans to disrupt robotic joint replacement surgery

The robot developer’s CEO, Benjamin Sexson, tells MedTech Dive why he believes the orthopedics market needs a fresh approach to joint reconstruction.

By Susan Kelly • Aug. 4, 2023

Penumbra says stroke device delayed at least 12 months due to FDA request

The setback stalls “a meaningful new product catalyst,” but the growth of Penumbra’s other devices could cushion the impact, analysts said.

By Nick Paul Taylor • Aug. 4, 2023

Outset pauses shipments of dialysis accessory after FDA warning letter, denting sales outlook

The halt prompted the company to predict it will now hit the bottom end of its full-year revenue range, a revision that surprised some analysts.

By Nick Paul Taylor • Aug. 4, 2023