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

Dexcom recalls more than 2 million CGM receivers for lack of audible alarm

1 week ago | medtechdive.com | Elise Reuter

A problem with Dexcom’s receivers for its glucose sensors may cause people to not get an audible alert for low or high blood sugar levels, the Food and Drug Administration said in an enforcement report posted Monday. More than 2 million devices are affected by the Class I recall, the highest risk category. The receiver, a handheld device that gives glucose readings, may not provide an audible alert due to a manufacturing problem.
Anne Wojcicki wins bid to buy back 23andMe for $305M

1 week ago | medtechdive.com | Elise Reuter

Anne Wojcicki, co-founder and former CEO of 23andMe, will buy back “substantially all” of the genetic testing firm's assets, 23andMe announced Friday. A bankruptcy court must still approve the sale. The nonprofit TTAM Research Institute — an acronym for 23andMe — outbid Regeneron with a purchase price of $305 million. Biotechnology firm Regeneron had offered $256 million, and the company was selected as the backup bidder, according to the announcement.
Abbott’s new diabetes leader on latest sensors, partnerships and Type 2 coverage

2 weeks ago | medtechdive.com | Elise Reuter

Abbott has been growing its diabetes business, striking partnerships and expanding its continuous glucose monitors to more people with Type 2 diabetes. Meanwhile, the company is developing a new type of sensor, one that can detect both glucose and ketones. Abbott also partnered last year with competitor Medtronic, agreeing to that will specifically work with Medtronic’s insulin pumps, pens and automated insulin delivery algorithms.
Tandem, Abbott team on insulin delivery with glucose-ketone sensor

2 weeks ago | medtechdive.com | Elise Reuter

Tandem Diabetes Care and Abbott struck a partnership to develop automated insulin delivery systems using a dual insulin-glucose ketone sensor, the companies said Tuesday. Automated insulin delivery systems pair continuous glucose monitors with insulin pumps to adjust insulin doses in real time. No systems on the market today incorporate ketone sensing.
Medtronic names Kate Benedict president of acute care and monitoring

2 weeks ago | medtechdive.com | Elise Reuter

Name: Kate BenedictNew title: President of Medtronic’s Acute Care and Monitoring businessPrevious title: President of Flex’s global health solutions businessKate Benedict joined Medtronic as president of the company’s acute care and monitoring business, the company announced Monday. She will also serve on the leadership team for Medtronic’s medical surgical portfolio. Benedict has more than 25 years of experience in healthcare, including in medical devices and pharmaceuticals.
Judge rules J&J unit must pay $442M in antitrust case

2 weeks ago | medtechdive.com | Elise Reuter

A federal judge ruled on Thursday that a Johnson & Johnson subsidiary must pay $442 million in damages after a jury found last month that the company violated antitrust rules by withholding support to hospitals that bought reprocessed catheters. District Judge James Selna ruled that J&J must pay triple the $147 million in damages determined by the jury, as allowed under antitrust law. The amount is separate from costs and attorneys’ fees.
Medtronic removes tracheostomy tubes due to dislodging risk

3 weeks ago | medtechdive.com | Elise Reuter

Medtronic is recalling certain tracheostomy tubes because of the risk that the devices could dislodge, causing an emergency where the patient cannot breathe or their airway is blocked, according to a Thursday Class I recall notice from the Food and Drug Administration. The company sent a notice to customers on Feb. 26 asking them to quarantine and return all unused tubes from the affected lot.
Neuralink raises $650M to help expand patient access

3 weeks ago | medtechdive.com | Elise Reuter

Elon Musk’s Neuralink closed a $650 million funding in a Series E round, the company said Monday. The company said it plans to use the funds to expand patient access and “innovate future devices that deepen the connection between biological and artificial intelligence.”Neuralink also announced that its brain implant has entered clinical trials in three countries, and that five people with severe paralysis are now using the implant to control digital and physical devices.
Clairity receives FDA OK for breast cancer risk prediction tool

3 weeks 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 weeks 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.