Recor wins FDA panel’s backing for high blood pressure device

The advisers found the company’s renal denervation system is safe and effective, but several panelists expressed concern about the long-term durability of the treatment.

By Susan Kelly • Aug. 23, 2023

Bayer inks deal to commercialize Mahana’s prescription digital therapeutics

The multimillion-dollar distribution and marketing partnership comes amid a decline in funding for prescription digital therapeutic companies. 

By Nick Paul Taylor • Aug. 23, 2023

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

Levita’s surgeon-controlled arm for magnetic procedures gains 510(k) clearance

The device maker says the technology can reduce the need for an additional assistant in the operating room, driving efficiency.

By Nick Paul Taylor • Aug. 23, 2023

Medtronic raises earnings forecast amid supply chain, diabetes business improvements

The company also shared an update on the planned divestment of its monitoring and respiratory interventions segments.

By Elise Reuter • Aug. 22, 2023

Axonics appoints Kari Keese to CFO post as Dan Dearen retires

The retirement of company co-founder Dearen is “unexpected but not concerning,” Truist analyst Richard Newitter said.

By Susan Kelly • Aug. 22, 2023

Zimmer Biomet CEO Hanson departs for 3M

COO Ivan Tornos will become the orthopedic device maker’s new top executive.

By Elise Reuter • Aug. 22, 2023

Bruker to buy PhenomeX and its cell research tools for $108M

The life science tools sector is ripe for consolidation, according to analysts at TD Cowen.

By Susan Kelly • Aug. 18, 2023

Dexcom, Abbott ramp up DTC marketing amid fight for share of growing diabetes market

As insurers cover continuous glucose monitors for more people, device-makers are taking a page from the pharma marketing playbook.

By Elise Reuter • Aug. 17, 2023

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

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