MedTech Dive - Latest News /news/MedTech industry newsen-usTue, 01 Dec 2020 10:00:00 -0500Digital therapeutic De Novos climb with FDA nod to IBS treatment /news/fda-de-novos-mahana-digital-therapeutic-ibs/589813/<p>Despite a&nbsp;series of first-of-their-kind izations for such&nbsp;tech, total 2020 De Novo OKs&nbsp;currently match a 2019 low in recent years.</p>Maria RachalTue, 01 Dec 2020 10:00:00 -0500/news/fda-de-novos-mahana-digital-therapeutic-ibs/589813/Zimmer puts up $250M in surgical device deal, Boston Scientific nets $800M in BTG pharma sell-off /news/zimmer-acquires-ae-medical-boston-scientific-sells-btg-pharma-assets-serb/589885/<p>The pandemic hasn&#39;t stopped M&amp;A&nbsp;in the&nbsp;medtech&nbsp;industry, with Zimmer Biomet adding to its&nbsp;sternal closure device lineup via A&amp;E Medical and Boston Scientific streamlining business with a sale to specialty pharma&nbsp;group SERB.</p>Nick Paul TaylorTue, 01 Dec 2020 09:48:22 -0500/news/zimmer-acquires-ae-medical-boston-scientific-sells-btg-pharma-assets-serb/589885/iRhythm gains UK support for EKG system while awaiting key final rule from CMS /news/irhythm-ekg-system-gains-uk-support-awaits-CMS-final-rule/589867/<p>The ambulatory cardiac monitoring system is one of just six medtech products recommended this year in guidance from the U.K. National Institute for Health and Care Excellence. The focus is&nbsp;on individuals with suspected arrhythmias.</p>Maria RachalTue, 01 Dec 2020 07:42:58 -0500/news/irhythm-ekg-system-gains-uk-support-awaits-CMS-final-rule/589867/Nevro Q4 sales to drop as COVID-19 headwinds stiffen: analysts /news/nevro-q4-sales-to-drop-as-covid-19-headwinds-stiffen-analysts/589862/<p>If the change in&nbsp;tone reflects growing unwillingness of patients to get elective care as cases surge,&nbsp;as&nbsp;Baird analysts believe,&nbsp;the update could have implications for other medical device companies.</p>Nick Paul TaylorTue, 01 Dec 2020 05:33:29 -0500/news/nevro-q4-sales-to-drop-as-covid-19-headwinds-stiffen-analysts/589862/Fitbit data suggests potential for early COVID-19 detection using wearables /news/fitbit-data-suggests-potential-for-early-covid-19-detection-using-wearables/589860/<p>While the algorithm would generate&nbsp;far more false than true positives&nbsp;even when prevalence is high, researchers argue it could encourage more testing and precautions. The results have&nbsp;yet to be validated in a prospective study.</p>Nick Paul TaylorTue, 01 Dec 2020 04:49:33 -0500/news/fitbit-data-suggests-potential-for-early-covid-19-detection-using-wearables/589860/CMS expands ability for hospital-level care at 网络百家家乐真人视频home ahead of holiday virus spread /news/cms-expands-ability-for-hospital-level-care-at-网络百家家乐真人视频home-as-thanksgiving-surge-e/589818/<p>Six health systems received&nbsp;waivers to treat more than 60 acute conditions under the new program, which also tweaks earlier changes allowing ambulatory surgical centers to provide&nbsp;greater inpatient care.&nbsp;</p>Shannon MuchmoreMon, 30 Nov 2020 09:55:22 -0500/news/cms-expands-ability-for-hospital-level-care-at-网络百家家乐真人视频home-as-thanksgiving-surge-e/589818/Grail inks commercial pact with UK government for multi-cancer blood test /news/grail-uk-partner-for-cancer-blood-test/589789/<p>As&nbsp;competition mounts among liquid biopsy developers, the agreement gives Illumina target Grail the chance to validate its early detection tool in the real world and potentially secure access to the broader U.K. market.</p>Nick Paul TaylorMon, 30 Nov 2020 07:03:31 -0500/news/grail-uk-partner-for-cancer-blood-test/589789/IVDR notified body count inches up to 5 with TÜV Rheinland designation /news/ivdr-5th-notified-body-tuv-rheinland/589787/<p>The&nbsp;medtech&nbsp;notified bodies trade group urged swift action on potentially delaying the start date for the In Vitro Diagnostic Regulation if designations don&#39;t more than double by year&#39;s end.</p>Nick Paul TaylorMon, 30 Nov 2020 06:11:52 -0500/news/ivdr-5th-notified-body-tuv-rheinland/589787/Healthcare deals in Q4 predicted to fall from record-setting Q3: report /news/cb-insights-predict-digital-health-deals-decline-Q4/589742/<p>Market research firm CB Insights believes the&nbsp;drop will carry&nbsp;over into the digital health sector too, an area that&#39;s seen historic investor interest in 2020 amid the coronavirus pandemic.</p>Rebecca PiferWed, 25 Nov 2020 09:38:29 -0500/news/cb-insights-predict-digital-health-deals-decline-Q4/589742/Hospitals adopt new round of elective surgery restrictions, brace for Thanksgiving COVID-19 surge /news/new-electives-rules-as-hospitals-brace-for-COVID-surge-/589635/<p>The American College of Surgeons is among those placing new emphasis on factoring healthcare worker&nbsp;wellbeing into capacity decisions.</p>Maria RachalWed, 25 Nov 2020 08:55:29 -0500/news/new-electives-rules-as-hospitals-brace-for-COVID-surge-/589635/