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This edition of Quick Notes reviews Becton Dickinson’s increase in U.S. manufacturing of syringes, clearance of the twiist Automated Insulin Delivery system, a new indication for Amplify standalone bone graft putty, and Fujifilm’s AI-powered endoscopic imaging technology. Read More
This edition of Quick Notes reviews Wegovy’s new approval for cardiovascular event prevention, interchangeable approvals for biosimilars for Prolia and Xgeva, Biocon and Janssen’s settlement agreement for a Stelara biosimilar, and a Regeneron drug for inherited high cholesterol in children. Read More
This week, a company pares down those giant robotic surgery systems, a drug-coated angioplasty balloon opens coronary arteries with pressure and medication, an ablation system eases the pain of metastatic bone lesions, and a new fixation device stabilizes the sacroiliac joint without the need for lateral screws. Read More
This edition of Quick Notes looks at the FDA alerts and letters regarding artificial ankle failures, operating tables moving unexpectedly and unlatched incubator panels. Read More
This week, critics complain that the Biden administration just doesn’t get Bayh-Dole, the DOJ hands BioMarin a subpoena, another Humira biosimilar snags FDA OK, and Novo Nordisk sticks a deal for molecular glue. Read More
This edition of Quick Notes looks at news in the medical device industry with Medtronic exiting the ventilator market, an FDA warning letter for a nasal spray, and FDA clearances for the first robotic assistant for shoulder surgery and an electrophysiological home monitor system. Read More
This edition of Quick Notes looks at significant drug approvals, including the first cellular therapy for patients with unresectable or metastatic melanoma, a drug to reduce accidental food allergy reactions, Tagrisso with chemotherapy for patients with EGFR-mutated advance lung cancer and a dosage reduction for patients with relapsed or refractory multiple myeloma. Read More
This edition of Quick Notes looks at consequential new drug approvals, including a first drug for frostbite, a first of its kind gene therapy authorization for sickle cell disease and transfusion-dependent beta thalassemia, supplemental approvals for pancreatic and non-small cell lung cancer and a treatment for an inflammatory esophageal condition. Read More
This week, your watch can start alerting you to sleep apnea, a fingertip clip can monitor your daytime blood oxygen, and a robotic exoskeleton can help restore mobility to spinal cord injury patients. But in a refreshing win for actual humans, a large study finds that the surgeon’s hands are just as good as robotic techniques in arthroscopic knee repair. Read More
This edition of interesting device approvals and clearances includes a pulsed field ablation system, a transesophageal echocardiography ultrasound transducer, a digital cytology system that combines deep-learning-based AI, and a deep brain stimulation system. Read More
Lapses in digital security, missed report deadlines, and a complete lack of quality oversight earned manufacturers some notable 483s. And here’s a first: How about getting written up for being too clean? Read More