Boston Scientific gets FDA nod for latest device in fast-growing Watchman franchise

Analysts at RBC Capital Markets called the Watchman FLX Pro approval an “incremental positive” for Boston Scientific.

By Nick Paul Taylor • Sept. 7, 2023

Synchron brain-computer interface implanted in first 6 US patients

The device is intended to give people with severe paralysis the ability to use their thoughts to perform everyday functions, such as online communications, hands-free.

By Susan Kelly • Sept. 6, 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

Abbott to buy smart insulin pen cap maker Bigfoot

The planned acquisition could shift patients interested in smart pens to Abbott’s Libre CGMs, an analyst wrote.

By Elise Reuter • Sept. 6, 2023

Illumina names Agilent’s Jacob Thaysen as its next CEO

The appointment comes less than three months after former CEO Francis deSouza stepped down following a proxy battle.

By Susan Kelly • Sept. 5, 2023

Medtronic sued for allegedly sharing ‘treasure trove’ of diabetes patient data with Google

The plaintiff said disclosures to Google are “particularly problematic” because his use of Gmail meant his personal information was “automatically linked to his real identity.”

By Nick Paul Taylor • Sept. 5, 2023

Noah Medical lung biopsy robot exceeds expectations in first-in-human trial

The startup presented early data on its FDA-cleared system at a meeting of pulmonologists in Chicago.

By Susan Kelly • Sept. 1, 2023

Spine volumes to grow 6.5% next year as post-pandemic boost continues: analysts

Use of robotic systems in spine surgeries also is on the rise, according to the latest poll by BTIG.

By Nick Paul Taylor • Sept. 1, 2023

ZimVie’s Rebecca Whitney sizes up the competition in cervical disc implants

The company is bringing new products to market as it faces more challengers in cervical disc replacement and tethering for scoliosis.

By Elise Reuter • Sept. 1, 2023

Beta Bionics raises $100M to challenge Medtronic, Tandem for automated insulin dosing market

The company’s iLet Bionic Pancreas automates insulin dosing without requiring mealtime carb counting. 

By Nick Paul Taylor • Sept. 1, 2023

Abbott study shows benefits of OCT imaging in stent placement

Optical coherence tomography improved doctors’ ability to place stents, but the study did not meet its primary goal for reducing a composite of deaths, heart attacks and repeat procedures. 

By Susan Kelly • Aug. 31, 2023

UK regulators name 3 approved bodies to ease device certification bottleneck

A MHRA leader hailed the action as “almost doubling capacity for medical device assessment in the U.K.”

By Nick Paul Taylor • Aug. 31, 2023

Hamilton Medical’s urgent ventilator notice deemed Class I recall by FDA

The company contacted customers in June after learning that long-term use of the devices could cause them to stop providing active ventilation.

By Nick Paul Taylor • Aug. 31, 2023

Why medtech firms are putting diabetes tech in consumer devices

As Abbott develops a line of wearable wellness devices, and Dexcom makes a CGM for people with diabetes who don’t take insulin, both companies are turning to new users for future growth.

By Elise Reuter • Updated Aug. 31, 2023

Trade groups urge CMS to expand, quickly finalize breakthrough device pathway

The groups want changes that include expanding the program to cover breakthrough diagnostics and previously authorized products.

By Nick Paul Taylor • Aug. 30, 2023

Hopes dim for Medtronic hypertension treatment after FDA panel rebuff

Analysts foresee hurdles to reimbursement even if the device wins the agency’s nod, and some don’t expect approval at all.

By Susan Kelly • Aug. 29, 2023

GE HealthCare rolls out software to speed assessment of AFib patients

The program aims to cut the time physicians spend searching multiple systems to understand the cardiac history of AFib patients.

By Nick Paul Taylor • Aug. 29, 2023

Medtronic identifies patients at increased risk of heart pump failure

The company has recalled its HeartWare HVAD pump multiple times since it was pulled from the market in 2021.

By Elise Reuter • Aug. 29, 2023

3M reaches $6B settlement to resolve combat earplug lawsuits

The agreement is much less than the $10 billion forecast by analysts.

By Nick Paul Taylor • Aug. 29, 2023

Boston Scientific’s pulsed field ablation device matches standard of care in AFib trial

RBC analysts forecast “conversion of 80% to 90% of the market over a 2-3 year period” after seeing the Farapulse data.

By Nick Paul Taylor • Aug. 28, 2023

US signs consent decree requiring EPA to finalize ethylene oxide rule by March

A medtech trade group called the deadline inadequate for the EPA to complete the “substantial” work that remains.

By Nick Paul Taylor • Aug. 28, 2023

VC funding in medtech ticks up, raising hopes that slump has bottomed

Analysts also forecast renewed interest in M&A now that large companies have worked through a string of spinoffs.

By Nick Paul Taylor • Aug. 25, 2023

Medtronic’s endovascular artificial intelligence pilot program treats first patient

A physician in the pilot used a 3D map of patient tissue in the image-guided minimally invasive surgery.

By Nick Paul Taylor • Aug. 25, 2023

‘Business as usual’ at Zimmer Biomet despite sudden CEO change

Incoming Chief Executive Ivan Tornos could accelerate the orthopedics company’s turnaround through acquisitions and by expanding its margins, analysts said.

By Elise Reuter • Aug. 24, 2023

Medtronic renal denervation device hits setback at FDA panel

The agency’s outside advisers found the risks of the procedure to lower blood pressure outweighed the benefits in a narrow vote.

By Susan Kelly • Aug. 24, 2023

Draeger’s ventilator sound insulation recall triggers FDA Class I notification

The company found concentrations of a potentially carcinogenic foam component were above acceptable levels for children.

By Nick Paul Taylor • Aug. 24, 2023