Diagnostic Makers Launch U.S. Test Registry To Target Covid-19 Hot Spots

July 30, 2020 The effort is a partnership of the Advanced Medical Technology Association (AdvaMed) and 13 of its member companies:  Abbott Laboratories; Becton Dickinson; bioMérieux; Bio-Rad; Beckman Coulter; Cepheid; Hologic; Ortho Clinical Diagnostics; Qiagen, Roche Diagnostics; Sekisui Diagnostics; Siemens Healthineers; and Thermo Fisher Scientific. Already, the companies involved are shipping more than 800,000 tests … Read more

Hahn testifies on COVID-19 response, says FDA on target to hit user fee goals

July 24, 2020 User fee goals, policy review Despite an “incredible surge in volume” of applications and constraints on the Agency’s ability to conduct inspections, Hahn said that FDA, “has maintained the same pace of meeting its goals on applications for medical products for the last six months that is has maintained in recent years.”  … Read more

Imaging Reveals Emerging Post-COVID Disease in Children

July 21, 2020 Known as Multisystem Inflammatory Syndrome in Children (MIS-C), this condition is characterized by airway inflammation, rapid development of pulmonary edema, coronary artery aneurysms, and extensive intra-abdominal inflammatory changes.  A team of investigators from Evelina London Children’s Hospital in London assessed these findings in children admitted to the hospital and published their findings … Read more

FDA finalizes contentious guidance on third party 510(k) reviews

July 16, 2020 Brief: The final guidance issued in March hews closely to the partly disputed draft, with the most common change being the adoption of 3P510k, rather than 3P, as the abbreviation for the program.  FDA did acquiesce to the pushback in some areas, for example by clarifying that review organizations should do assessments … Read more

EC eases rules for renewing notified body designations, explains process for EU-wide derogations

July 14, 2020 The move comes as the Commission works to realign the various components of its regulatory framework for medical devices to accommodate the one-year MDR delay necessitated by the coronavirus disease (COVID-19) pandemic and the two-year Eudamed delay announced last year. The Commission also released guidelines on in May explaining the process and … Read more

Becton Dickinson Wins FDA Approval of 15-Minute, Hand-Held Covid Test

July 10, 2020 The hand-held product, which is around the size of a mobile phone, is part of a new class of antigen testing technology that promises to bring faster, cheaper testing to doctors’ offices, urgent-care centers and other medical facilities.  The first such test, from Quidel Corp., was cleared for U.S. use in May.  … Read more

AdvaMed’s Whitaker calls for pandemic cooperation

July 07, 2020 In an interview on the Device Talks Weekly podcast, Whitaker laid out steps he believes the federal government and med-tech industry must take, including addressing medical device and supply stockpiles and strengthening supply chains.  Above all, Whitaker said, any response is strongest when government and industry work together, a lesson learned early … Read more

To build eye implants, developer looks 250 miles up

July 02, 2020 LambdaVision, with a lift from its partner Space Tango, scored $5 million from NASA to test how microgravity could affect the production of its artificial retinas.  The company aims to tackle retinitis pigmentosa, a rare genetic disorder that damages the light-sensing cells lining the back of the eye.  It has been developing … Read more

Harvard spins out biologics-in-a-pill company with a focus on Type 1 diabetes

July 01, 2020 In 2018, researchers in the bioengineering laboratory of Harvard’s Samir Mitragotri published their methods for turning liquid drugs into a newly encapsulated and easy-to-swallow form, and demonstrated early success with insulin in animal models. Now, i2O Therapeutics is starting out with $4 million in seed money — from Sanofi Ventures and the … Read more