Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cepheid, Conformis, Guide Sensmart, Oxford Immunotec, Surgical Innovation Associates.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accelerate Technologies, Aptorum Group, Billiontoone, Confirm Biosciences, Exagen, Genosity, Infirmary Health, Inflammatix, Karl Storz, Labcorp, LC-SCRUM-Asia, Jellagen, Mayo Clinic, Olink Proteomics, Premier, Proterixbio, Provider Network of America, Pulse Biosciences, Radiant Technologies, Saranas, Securiport, Seek Thermal, Stryker, Swift Biosciences, Wright Medical, Thermo Fisher Scientific, Well Health Technologies.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Immunovia, Irras, Istar Medical, Medasense, Moleculight.
New hires and promotions in the med-tech industry, including: Aziyo, Bioaffinity Technologies, Cyted, Deep Genomics, Exthera, Madaket, Omniome, Orb Health, Prometheus Biosciences, Solutionreach, Theralink Technologies.
Keeping you up to date on recent developments in oncology, including: New nanoparticle could overcome aggregation-caused quenching for cancer treatment; Epigenetic resistance to PARP inhibitors; Statins help pancreatic tumors go from bad to worse; Sit up straight: PBT coming to a chair near you.
PARIS – Miracor Medical SA secured a $28 million series E funding round for its Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) impulse system, intended for treating patients presenting with ST-Elevation Myocardial Infarction (STEMI). “This funding will be used to move the PiCSO clinical trial program forward, and to begin distributing our technology in Europe,” Olivier Delporte, CEO of Miracor, told BioWorld.
KARACHI, Pakistan – Faced with lockdowns and massive disruptions to supply chains, distributors and manufacturers of surgical equipment in countries across South Asia like Pakistan, Indian, Bangladesh and Nepal are struggling to find a way forward but also looking for opportunities to expand their share of the global market while reducing their existing reliance on imports of basic supplies.
The U.S. FDA’s effort to compile a guidance for prescription, point-of-care (POC) blood glucose meter (BGM) test systems seems to show that guidances can be as iterative as the devices they govern. The FDA announcement for the Sept. 28, 2020, final guidance said that the differences between the 2020 final and the 2018 draft include “a minor edit” regarding user accessibility and a technical correction for hemoglobin testing concentration, yielding a document that is finally ready for prime time after four tries over six years.
Abbott Laboratories is celebrating another win with its continuous glucose monitoring (CGM) technology. This time, the company revealed that it has scored the CE mark for its next-generation Freestyle Libre 3 system. Wells Fargo’s Larry Biegelsen noted that the arrival of the CE mark came slightly earlier than his group had expected.
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