FDA eases rules on remote patient monitoring devices during pandemic
The FDA has relaxed regulations on 21 types of remote patient monitoring devices for the […]
The FDA has relaxed regulations on 21 types of remote patient monitoring devices for the […]
The FDA has relaxed regulations on 21 types of remote patient monitoring devices for the […]
GTX Medical this week said it received FDA breakthrough device designation for its Go-2 targeted […]
Dive Brief: Boston Scientific on Monday said CMS approved its application for a transitional pass-through payment […]
Clew Medical recently received FDA emergency use authorization for its ClewICU System for use in intensive […]
Dive Brief: FDA has warned clinical laboratory staff and healthcare providers against using certain transport […]
Insulet (NSDQ:PODD) today said it has resumed its pivotal study of its next-generation Omnipod Insulin Management […]
The FDA granted emergency use authorization (EUA) for emergency COVID-19 ventilator devices developed by Nasa […]
Diabetes treatment tech company Bigfoot Biomedical announced today that it raised $55 million to close its Series […]
Dive Brief: Clinical trials of invasive cardiovascular interventions are often “relatively small and fragile” and […]
Abiomed (NSDQ:ABMD) announced that it received FDA emergency use authorization (EUA) for its Impella RP for […]
Dive Brief: FDA has released a reference panel to help commercial and laboratory developers of coronavirus […]
A team of physicians and engineers developed a hands-free resuscitator bag compression device that can […]
Merit Medical (NSDQ:MMSI) announced that it received CE Mark approval in Europe for its Wrapsody endovascular […]
Dive Brief: FDA will allow companies to make “limited modifications” to medical devices marketed under […]
Early this week cardiac-focused digital health company Eko scored a temporary Emergency Use Authorization (EUA) […]
Dive Brief: Health tech giant Philips and diagnostic imaging startup Caption Health announced FDA clearances […]
– Alinity m is Abbott’s new molecular lab system, which was approved by the U.S. […]
Becton Dickinson (NYSE:BDX) said today that it has stopped selling a point-of-care test touted as being […]
The Food and Drug Administration recently awarded a breakthrough device designation for a phototherapy device […]
VALENCIA, Calif., May 06, 2020 (GLOBE NEWSWIRE) — SetPoint Medical, a clinical-stage bioelectronic medicine company […]
Ambu announced today that it will launch its Ambu aView 2 Advance display unit for use […]
Pulmonx announced today that it raised $66 million in a financing round led by global life […]
Astura Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) for […]
Liberate Medical, a company based outside of Louisville, Kentucky, won FDA Emergency Use Authorization for […]
Dive Brief: FDA awarded a first-of-its-kind emergency use authorization to a respiratory muscle stimulator device […]
While NASA took enterprising steps last week toward returning astronauts to the moon by 2024, it also […]
The FDA issued a notice today warning that its recall of the Vascular Solutions Langston dual lumen […]
Dive Brief: Medtronic received De Novo authorization from FDA for a device designed to provide […]
Pear Therapeutics is rolling out its new digital therapeutic aimed at treating schizophrenia for limited […]
Coala Life today said it expanded its monitoring capabilities to monitor COVID-19 patients from home. […]
Dive Brief: FDA on Monday sent an update to healthcare providers describing risks associated with […]
Dive Brief: A slate of high profile former health officials from the Trump and Obama […]
A new FDA policy aiming to boost access to digital health devices for treating psychiatric disorders during […]
The FDA has granted Royal Philips (NYSE:PHG) an emergency use authorization for one of its IntelliVue bedside […]
LivaNova (NSDQ:LIVN) announced that some of its cardiopulmonary products are now permitted for extended use in […]
Dive Brief: FDA published a final guidance document Tuesday that establishes a standard method for medical […]
Digital health companies are quickly embracing changes by the Food and Drug Administration that would […]
Vent Multiplexor LLC announced that it received FDA Emergency Use Authorization for its device that […]
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