Elise Reuter

Denver

Reporter @MedTechDive covering medical devices and digital therapeutics. Tips: ereuter at industrydive dot com or 619 736 9409 for Signal. She/her.

Articles

Clairity receives FDA OK for breast cancer risk prediction tool

3 days ago | medtechdive.com | Elise Reuter

The Food and Drug Administration has authorized the first artificial intelligence tool to predict patients’ five-year breast cancer risk from a routine mammogram. Boston-based startup Clairity developed the tool, called Clairity Breast. The company plans to launch the risk assessment feature by the end of the year, according to a Monday announcement.
Nvidia’s David Niewolny on the future of AI in medical devices

3 days ago | medtechdive.com | Elise Reuter

As more medical device companies incorporate artificial intelligence, chip designer Nvidia is playing a central role. The company has struck partnerships with top medtech firms including Medtronic, Johnson & Johnson, GE Healthcare and Philips. The uses span a breadth of technologies.
Boston Scientific ends TAVR sales; J&J shares Monarch robot data

1 week ago | medtechdive.com | Elise Reuter

Boston Scientific said Wednesday it plans to end worldwide sales of its transcatheter aortic valve replacement systems, citing regulatory hurdles. The company will discontinue its Acurate Neo2 and Acurate Prime TAVR systems, which are sold in Europe, and will not pursue Food and Drug Administration approval for the devices.
Why Medtronic plans to spin out its diabetes business

2 weeks ago | medtechdive.com | Elise Reuter

After working for years to turn around its diabetes business, Medtronic announced plans on Wednesday to spin out the unit. The decision raised questions among analysts about why Medtronic would exit a growing market as more people adopt diabetes technology. “We’re left asking why?” J.P. Morgan analyst Robbie Marcus wrote in a research note.
AI in medtech is booming. Track new devices here.

2 weeks ago | medtechdive.com | Elise Reuter

Artificial intelligence has become a buzzword in the medtech industry as more medical devices incorporate the technology. Device companies are using AI to speed up imaging, triage CT scans for serious conditions and identify potential heart arrhythmias. The Food and Drug Administration is also fielding more submissions in recent years, with the 223 AI devices authorized in 2023 being the most in the agency’s history.
J&J subsidiary ordered to pay $147M for violating antitrust rules

2 weeks ago | medtechdive.com | Elise Reuter

A California jury ruled on Friday that Biosense Webster, a subsidiary of Johnson & Johnson, broke antitrust rules by withholding clinical support to hospitals using reprocessed catheters. The lawsuit was filed by medical device reprocessing firm Innovative Health in 2019. The jury awarded Innovative Health more than $147 million in damages, according to court documents. Law360 first reported the verdict on Friday.
Dexcom CEO says CGMs fit MAHA agenda ‘very nicely’; Tandem preps for new products

3 weeks ago | medtechdive.com | Elise Reuter

Dexcom CEO Kevin Sayer touted the company’s recent efforts to expand coverage of CGMs for people with Type 2 diabetes. On a May 1 earnings call, the CEO told investors that all three major U.S. pharmacy benefit managers now cover the company’s G7 glucose monitor for anyone with diabetes. Dexcom expects to have coverage for nearly 6 million people with Type 2 diabetes who don’t take insulin by the end of the year.
Roche to expand, open Indianapolis and North Carolina sites

3 weeks ago | manufacturingdive.com | Elise Reuter

Roche Diagnostics will build a $550 million expansion to produce continuous glucose monitors at an Indianapolis facility. Roche will use the site to make its Accu-Chek Smartguide devices, which launched last year in Europe as the company’s first continuous glucose monitoring device. The company will also build a new $700 million factory in Holly Springs, North Carolina. The facility, which is expected to create at least 400 jobs, will produce Roche’s future portfolio of obesity medicines.
Embecta restructures again, outlines tariff costs

3 weeks ago | medtechdive.com | Elise Reuter

Embecta began a restructuring plan in its fiscal second quarter, the company announced on Friday, its second organizational change since November. The cuts are intended to “streamline the organization and optimize resources,” and are separate from a restructuring related to the company discontinuing its insulin patch-pump program, which was announced about six months ago. Embecta did not confirm with MedTech Dive the number of people who will be affected by the restructuring announced Friday.
Roche plans $550M expansion of Indianapolis site to manufacture CGMs

3 weeks ago | medtechdive.com | Elise Reuter

Roche Diagnostics will build a $550 million expansion to produce continuous glucose monitors at an Indianapolis facility. Roche will use the site to make its Accu-Chek Smartguide devices, which launched last year in Europe as the company’s first CGM. “Our goal is to initiate production within three years, followed by preparing for future generations of that CGM solution,” Richeal Cline, head of global operations for Roche Diagnostics, said in a Monday press conference.