Dexcom (NSDQ:DXCM) today shared results from two studies of continuous glucose monitors, including its next-generation G7 CGM. San Diego-based Dexcom presented the studies during the 14th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD). Get the full story at our sister site, Drug Delivery Business News.
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Medtronic stops sales of its HVAD system
Medtronic (NYSE:MDT) announced today that it has stopped distributing and selling its HeartWare Ventricular Assist Device (HVAD) system. Fridley, Minn.-based Medtronic this morning issued a notice to physicians informing them to stop new implants of the HVAD system and to transition to an alternative means of durable mechanical circulatory support, according to a news release. […]
Abiomed buys PreCardia and its heart failure treatment system
Abiomed (NASDAQ: ABMD) announced this week that it has acquired PreCardia and its catheter-based system to treat acute decompensated heart failure. The financial terms of the deal were not disclosed in the June 1 announcement. Abiomed officials say the deal complements the company’s product portfolio, expanding options for patients with acute decompensated heart failure. The […]
DTW Podcast: How Josh Makower wrote the book(s) on medtech innovation
Dr. Josh Makower quite possibly invented modern-day medtech innovation. In this interview, Makower shares his earliest inventions — kind of mind-blowing — and how his early work at Pfizer helped him create the innovation process used today by biodesign programs across the world, including Stanford Biodesign where Dr. Makower will take over as director this […]
FTC drops Illumina-Grail court case, clearing the way for EU investigation
A U.S. judge has ruled in favor of an FTC petition to drop its case against the proposed merger between Illumina (NSDQ:ILMN) and Grail. The Financial Times reported that the ruling — with dropped the case without prejudice — allows the EU to investigate the merger while the deal remains blocked. In April the European Commission’s […]
Study shows CGMs better at controlling blood sugar in type 2 diabetes
Kaiser Permanente is touting a study demonstrating that using continuous glucose monitors offers better blood sugar control for patients with type 2 diabetes. Patients with insulin-treated type 2 diabetes using continuous glucose monitors (CGMs) typically had better blood sugar control and fewer visits to the emergency room for hypoglycemia, the study found. The study was […]
New FDA-backed initiative seeks to boost diversity in medtech
MedTech Color has launched a Collaborative Community on Diversity and Inclusion in Medical Device Product Development and Clinical Research. The MedTech Color Collaborative Community aims to bring together public and private stakeholders and develop targeted strategies to up the awareness, understanding and participation of racial and ethnic minorities within the medtech industry, according to a […]
FDA seeks more money, authority in budget request
The FDA wants more money from Congress for the coming fiscal year — and more power, too. Out of its $6.5 billion total budget, the agency is asking $676.55 million for its medical device program. That includes $571 million for the Center for Devices & Radiological Health (CDRH) and $105.4 million for the Office of Regulatory […]
Medtronic touts real-world results for MiniMed 780G insulin pump
Medtronic (NYSE:MDT) today announced positive real-world outcomes for thousands of patients using the MiniMed 780G insulin pump system. Fridley, Minn.-based Medtronic’s MiniMed 780G system automates and personalized the delivery of basal insulin through adjustments every five minutes for 24 hours a day. It includes an advanced algorithm designed to automatically correct highs every five minutes through […]
FDA authorizes Cognoa autism spectrum disorder diagnostic aid
U.S. FDA today authorized Cognoa’s machine learning-based software to help diagnose autism spectrum disorder. The de novo authorization from FDA covers the use of the Cognoa ASD Diagnosis Aid with children 18 months through 5 years of age with potential ASD symptoms. Palo Alto, Calif.–based Cognoa has touted the software as a way to do away […]
Edwards’ low-BP prediction software gains FDA clearance
Edwards Lifesciences (NYSE:EW) has announced that its Acumen hypotension prediction index (HPI) software has received FDA 510(k) clearance. Using data obtained from the Acumen IQ finger cuff, the software uses machine learning to alert clinicians of the likelihood a patient is trending toward hypotension, or low blood pressure. Until now, Acumen HPI software has only […]