J&J-backed HistoSonics gets de novo clearance for liver cancer treatment

The system offers a minimally invasive alternative to surgical resection and thermal ablation in patients with primary and metastatic liver cancers.

By Nick Paul Taylor • Oct. 10, 2023

Clinicians ‘love yet fear’ AI, say medtech leaders

Stryker, Siemens Healthineers and Google execs said at the MedTech Conference that digital technology can help with patient care, but healthcare professionals also worry about it taking their jobs.

By Elise Reuter • Oct. 10, 2023

Explore the Trendline➔

Top 5 stories from MedTech Dive

From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

Insulet wins preliminary injunction against EOFlow in patent suit

A federal judge has blocked EOFlow, a company that Medtronic plans to acquire, from selling its insulin patch pump.

By Susan Kelly • Oct. 9, 2023

J&J could reach market-leading medtech growth after consumer spinoff: analysts

The analysts identified J&J’s leadership position in 11 categories, shift to fast-growing markets and investment in robotics as strengths.

By Nick Paul Taylor • Oct. 9, 2023

Best Buy to sell continuous glucose monitoring systems

It’s the tech retailer’s first foray into prescription-based medical device sales.

By Rebecca Pifer • Oct. 9, 2023

FDA says Philips’ testing of recalled devices is inadequate

The regulator called for further tests to evaluate health risks posed to patients from the sound abatement foam used in the devices.

By Elise Reuter • Oct. 6, 2023

GE HealthCare imaging CEO Jan Makela talks Mayo Clinic partnership

GE and Mayo Clinic plan to collaborate on imaging, artificial intelligence and cancer treatment.

By Elise Reuter • Oct. 6, 2023

Catheter ablation beats drugs in J&J retrospective study of AFib heart failure risk

Patients who received catheter ablation had a 57% lower risk of developing heart failure than their counterparts on antiarrhythmic drugs.

By Nick Paul Taylor • Oct. 6, 2023

Medtronic hires neuromodulation president from Smith+Nephew

Paolo Di Vincenzo will oversee strategy and operations for pain interventions and brain modulation.

By Susan Kelly • Oct. 5, 2023

Medtronic posts warning after stolen, defective intubation devices advertised for sale

The notice covers McGrath MAC video laryngoscopes that were designated for destruction and never released for sale.

By Nick Paul Taylor • Oct. 5, 2023

Akura Medical secures $35M to pursue FDA clearance for thrombectomy device

The money also will help fund clinical trials for additional indications and the expansion of its manufacturing capabilities.

By Susan Kelly • Oct. 4, 2023

Duke researchers find app improves autism screening in NIH-funded study

Participants who screened positive for autism had a nearly 41% probability of being diagnosed with the condition.

By Nick Paul Taylor • Oct. 4, 2023

Baxter hires new CFO from food industry

Joel Grade will join the company after 25 years at Sysco.

By Elise Reuter • Oct. 3, 2023

FDA expands total product life cycle program to cover neurological devices

The agency could enroll up to 45 additional devices over the coming year.

By Nick Paul Taylor • Oct. 3, 2023

FDA details switch to electronic filings for 510(k), de novo submissions

The guidance documents advance the transition to eSTAR, an electronic template the FDA is adopting to meet legislative requirements.

By Nick Paul Taylor • Oct. 3, 2023

Friend, not foe: How AI will revolutionize patient care

Artificial intelligence should be embraced to help streamline data and tackle clinician burnout, says Medtronic’s Stacey Churchwell.

By Stacey Churchwell • Oct. 2, 2023

Accuray’s Suzanne Winter to lead AdvaMed radiotherapy sector

Winter, the CEO of Accuray, succeeds Baxter’s Chris Toth as chair of the trade group’s radiation therapy sector.

By Susan Kelly • Oct. 2, 2023

Medtronic in exclusive talks for $7B sale of units to private equity: report

The Carlyle Group is leading the race to buy Medtronic’s connected patient monitoring and respiratory care operations, Reuters reported.

By Nick Paul Taylor • Oct. 2, 2023

Healthtech companies dealing with complex device fleets, new report finds

Four ways HealthTech companies are using modern solutions to manage their mission-critical devices.

Oct. 2, 2023

FDA to regulate lab-developed tests under proposed rule

The tests have come under scrutiny by the agency and lawmakers, but the FDA is still likely to face pushback on the changes.

By Elise Reuter • Sept. 29, 2023

Abbott data suggests GLP-1 drugs a ‘modest accelerator’ for CGMs: analysts

The analysis of U.S. insurance claims found people on GLP-1 therapy wear their FreeStyle Libre sensors more.

By Nick Paul Taylor • Sept. 29, 2023

As government shutdown looms, medical device reviews expected to continue

The FDA could furlough nearly a fifth of its staff by Sunday if Congress doesn’t reach a funding agreement. 

By Elise Reuter • Sept. 28, 2023

Galen robot gets FDA de novo clearance for ENT surgeries

The startup affiliated with Johns Hopkins University said it is opening a bridge round for its series B financing as it targets more applications for the robotic surgery assistant.

By Susan Kelly • Sept. 28, 2023

Artificial heart maker’s cash runway shrinks to 1 month after supply woes hurt sales

France’s Carmat expects revenues of up to 6 million euros in the second half of the year but needs to secure financing to avoid running out of money.

By Nick Paul Taylor • Sept. 28, 2023

Harbinger Health raises $140M to study blood-based cancer screening test

The test developer will use the series B funding to complete a 10,000-subject clinical trial ahead of a planned launch in 2025.

By Nick Paul Taylor • Sept. 28, 2023