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Sean Whooley

Zacks says Medtronic will gain from expanded CMS coverage for CGMs

December 23, 2021 By Sean Whooley

Medtronic logo updated

Zacks Equity Research today reported that Medtronic (NYSE:MDT) stands to gain from yesterday’s CMS coverage expansion for diabetes technology. CMS’s expanded coverage, confirmed by Medtronic yesterday, covers all types of CGMs (continuous glucose monitors), including adjunctive and non-adjunctive CGMs. The coverage includes CGMs that integrate with Medtronic insulin pumps. Zacks said the new rule will likely […]

Filed Under: Auto-injectors, Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Patient Monitoring, Wall Street Beat Tagged With: Medtronic

CMS expands Medicare coverage to CGMs that integrate with Medtronic insulin pumps

December 22, 2021 By Sean Whooley

Medtronic World Diabetes Day

Medtronic (NYSE:MDT) announced today that the U.S. Centers for Medicare & Medicaid Services (CMS) will expand coverage for CGMs. CMS’ expanded coverage covers all types of CGMs (continuous glucose monitors), including adjunctive and non-adjunctive CGMs, and it notably covers CGMs that integrate with Medtronic insulin pumps. According to a news release, the proposed rule was […]

Filed Under: Auto-injectors, Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring Tagged With: Centers for Medicare and Medicaid Services (CMS), Medtronic, Reimbursement

Government warns on cybersecurity issue with Fresenius Kabi’s Agilia Connect infusion system

December 21, 2021 By Sean Whooley

Fresenius Kabi logo updated

The U.S. Cyber Security & Infrastructure Security Agency today issued a medical advisory for the Fresenius Kabi Agilia Connect infusion system. Fresenius Kabi’s Agilia Connect infusion system has been deemed “exploitable remotely/low attack complexity” by the agency. Successful exploitation of vulnerabilities could allow an attacker to gain access to sensitive information, modify settings or parameters […]

Filed Under: Auto-injectors, Drug-Device Combinations, Featured, Pharmaceuticals, Technology Tagged With: freseniuskabi, infusion pump, infusion systems

Senseonics wins CE mark for remote glucose monitoring app for Android users

December 21, 2021 By Sean Whooley

Eversense CGM Senseonics

Senseonics (NYSE:SENS) announced today that its Eversense NOW remote monitoring app for Android received CE mark approval. Germantown, Maryland-based Senseonics already received such approval for the Eversense NOW iOS platform and can now offer it in Europe on the Android operating system. The company expects to make the Eversense NOW remote monitoring app for Android […]

Filed Under: Big Data, Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring, Regulatory/Compliance, Technology Tagged With: Senseonics

12 of medtech’s biggest personnel changes in 2021

December 17, 2021 By Sean Whooley

Medtech personnel changes

As medtech companies continued to drive innovation throughout the past 12 months, a number of high-level executives led the way. Some of those companies and those executives opted for major changes over the course of 2021, though, with some high-profile moves from medtech giant to medtech giant. Here are some of the biggest personnel moves […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Personnel Tagged With: abbott, BD, Dexcom, embecta, Medtronic, Personnel, Personnel Moves

Boyd acquires MBK Tape Solutions, expands expertise in wearables, transdermal patches

December 16, 2021 By Sean Whooley

Boyd

Boyd Corporation announced today that it acquired MBK Tape Solutions and its multi-layered adhesive products. MBK manufactures and develops complex multi-layered adhesive products that bond, mount, monitor and protect for stick-to-skin applications in the regulated medical industry. Pleasanton, California-based Boyd said in a news release that the acquisition strengthens its medical material science capability across […]

Filed Under: Business/Financial News, Drug-Device Combinations, Mergers & Acquisitions Tagged With: Boyd, MBK Tape Solutions

Bigfoot Biomedical announces trio of new senior hires

December 16, 2021 By Sean Whooley

Bigfoot Biomedical smart insulin pen cap

Bigfoot Biomedical announced today that it appointed three senior hires with experience in the diabetes and healthcare sectors. Milpitas, California–based Bigfoot hired Matthew Clemente as SVP of development, Robin A. Beadle as VP of marketing and Scott Snead as VP of national accounts. All three positions are newly created. Bigfoot said in a news release […]

Filed Under: Auto-injectors, Big Data, Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring, Personnel Tagged With: Bigfoot Biomedical, Personnel, Personnel Moves

Alfred E. Mann Foundation brings former Alcon, Siemens Healthineers execs into C-suite

December 15, 2021 By Sean Whooley

Alfred Mann Foundation (1)

The Alfred E. Mann Foundation for Scientific Research (AMF) today confirmed the appointment of two new senior executives. Los Angeles-based AMF appointed Charles Nelson as its new COO and Corey Dishmon as its chief legal officer/chief business officer. Nelson joins AMF from Alcon, where he oversaw the manufacturing science and technology organization. He is a […]

Filed Under: Auto-injectors, Business/Financial News, Diabetes, Drug-Device Combinations, Featured Tagged With: Alfred E. Mann Foundation, Personnel, Personnel Moves

Medtronic Diabetes receives FDA warning over quality system requirement inadequacies

December 15, 2021 By Sean Whooley

Medtronic logo updated

Medtronic (NYSE:MDT) announced today that it received an FDA warning letter after an inspection of its Diabetes Business. The company received the letter on Dec. 9 for its Northridge, California facility — the Medtronic Diabetes Business headquarters — following an inspection that concluded in July 2021. FDA’s warning letter to Medtronic focused on the inadequacy […]

Filed Under: Auto-injectors, Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Recalls Tagged With: FDA, Medtronic

Virta Health touts triple-digit growth with insurers as market shifts toward diabetes reversal

December 14, 2021 By Sean Whooley

Virta Health

Virta Health announced today that it now works with more than 20 national and regional health plans, marking triple-digit growth. San Francisco-based Virta Health, which develops type 2 diabetes reversal technology, has now grown 133% year-over-year with large insurer customers that now offer its treatment to self-funded employer groups, including Humana and Providence Health Plan. […]

Filed Under: Business/Financial News, Diabetes, Featured Tagged With: Virta Health

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