Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Fluidigm.
The implementation date for the European Union’s In Vitro Diagnostic Regulation (IVDR) is a mere 16 months away, although there is widespread interest in a delayed implementation date. Nonetheless, Warren Jameson, principal regulatory consultant for North American Science Associates (NAMSA) of Toledo, Ohio, urged test makers to conduct a gap analysis of the conformity of their currently marketed tests to the new regulations because a large percentage of the underlying dossiers would not pass muster under the terms of the new regulatory regime.
HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) has greenlighted Seoul-based Vuno Inc.’s artificial intelligence (AI)-based solution Vuno Med Deepbrain for use as a class III medical device, which is a classification for moderate risk level devices. The MFDS approval was given on Dec. 29, 2021, a Vuno spokesperson told BioWorld, but the company only disclosed the approval earlier in the week. The reasons for the delayed announcement were not disclosed.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Hahn out, Woodcock in as acting FDA commissioner; White House orders regulatory freeze.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Canon Medical Systems, Covaxx, Lumiradx, Retia Medical, Zimmer Biomet.
A green light from the U.S. FDA has significantly brightened Seno Medical Instruments Inc.’s image of its immediate future. The San Antonio-based company developed a novel breast cancer imaging technology that combines noninvasive opto-acoustic (OA) technology with ultrasound (US) to more accurately distinguish benign from malignant breast lesions following ambiguous mammography results.
PARIS – France’s Comité Economique des Produits de Santé (CEPS), which reports to the Ministry of Health, has released its latest financial figures for medical device reimbursement. Health insurance expenditures amounted to $11.6 billion during the last full financial year reported by CEPS, representing annual growth of 4.66%. Over the last two years, more than half of expenditures have focused on four therapy areas: orthopedics, pulmonology/ENT, cardiac and vascular systems, and diabetes.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Lightpoint Medical, Omniguide Holdings, Renegade.bio.
When it comes to leveling the playing field for foreign-based biopharma and medical device companies, China has made a lot of promises, but delivering on those promises is what matters. Throughout its annual assessment for Congress of China’s commitment to World Trade Organization principles, the U.S. Trade Representative (USTR) noted the many promises China has made over the years that have yet to be kept.
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