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RSS FeedPosted by Michael Wonder on 17 Nov 2020
Sommetrics receives FDA breakthrough device designation for its aerSleep II product to treat sleep apnea
17 November 2020 - Sommetrics today announced its lead sleep apnea product, aerSleep II, has received FDA breakthrough device designation. ...
Posted by Michael Wonder on 12 Nov 2020
FDA grants a breakthrough device designation for Spiderwort spinal cord technology
12 November 2020 - Spiderwort is pleased to announce that the U.S. FDA has designated CelluBridge, Spiderwort’s spinal cord scaffold implant, ...
Posted by Michael Wonder on 09 Nov 2020
FDA permits marketing of new device designed to reduce sleep disturbance related to nightmares in certain adults
6 November 2020 - Today, the U.S. FDA permitted marketing of a new device intended for the temporary reduction of sleep ...
Posted by Michael Wonder on 04 Nov 2020
Salvia BioElectronics receives FDA breakthrough device designation for innovative neurostimulation solution
3 November 2020 - Salvia BioElectronics announced today that the U.S, FDA has granted breakthrough device designation for its implantable ...
Posted by Michael Wonder on 22 Oct 2020
AppliedVR receives FDA breakthrough device designation to treat pain with digital therapeutic
21 October 2020 - AppliedVR today announced its EaseVRx product received breakthrough device designation from the U.S. FDA for treating ...
Posted by Michael Wonder on 01 Oct 2020
Genetron Health receives U.S. FDA breakthrough device designation for its blood based NGS test for early detection of hepatocellular carcinoma
30 September 2020 - Genetron Holdings today announced that its blood-based next-generation sequencing test, HCCscreen, has been granted breakthrough device designation ...
Posted by Michael Wonder on 01 Sep 2020
FDA approves first-of-its-kind automated insulin delivery and monitoring system for use in young paediatric patients
31 August 2020 - Today, the U.S. FDA approved the MiniMed 770G System, a hybrid closed loop diabetes management device that ...
Posted by Michael Wonder on 31 Aug 2020
FDA approves Xaracoll (bupivacaine hydrochloride) implant, a non-opioid, drug-device treatment option for acute post-surgical pain relief for up to 24 hours following open inguinal hernia repair in adults
31 August 2020 - Xaracoll is a first-of-its-kind, fully bioresorbable collagen implant that delivers bupivacaine hydrochloride directly to the surgical site ...
Posted by Michael Wonder on 31 Aug 2020
FDA releases draft guidance on PROs for device manufacturers
31 August 2020 - Device manufacturers have new draft guidance from the US FDA for the selection of patient-reported outcome ...
Posted by Michael Wonder on 07 Aug 2020
FDA approves first liquid biopsy next generation sequencing companion diagnostic test
7 August 2020 - Today, the U.S. Food and Drug Administration approved the first liquid biopsy companion diagnostic that also uses ...
Posted by Michael Wonder on 05 Aug 2020
Roche announces FDA authorisation for the first Epstein-Barr virus quantitative test on the cobas 6800/8800 Systems to improve care for transplant patients
5 August 2020 - FDA granted de novo class II for cobas EBV test following the agency’s breakthrough device designation. ...
Posted by Michael Wonder on 17 Jun 2020
Most coronavirus tests cost about $100. Why did one cost $2,315?
16 June 2020 - U.S. health care prices are unregulated, opaque and unpredictable. When Congress required insurers to cover COVID-19 testing, ...
Posted by Michael Wonder on 06 Apr 2020
COVID-19 update: daily roundup 6 April 2020
6 April 2020 - The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort ...
Posted by Michael Wonder on 20 Mar 2020
Generating comparative evidence on new drugs and devices before approval
21 March 2020 - Fewer than half of new drugs have data on their comparative benefits and harms against existing treatment ...
Posted by Michael Wonder on 17 Mar 2020
FDA provides more regulatory relief during outbreak, continues to help expedite availability of diagnostics
16 March 2020 - Today, as part of our ongoing and aggressive commitment to address the coronavirus outbreak, the FDA updated ...