DeepLook Gets FDA Clearance for Imaging Software July 12, 2021 DL Precise is the first of a series of medical imaging products under development by the New Haven, Conn.-based company. Read More
Flowsion Earns CE Mark for Glucose Control Device July 12, 2021 The automated system can help increase survival rates and lower treatment costs at the same time, the company said. Read More
AliveCor’s Personal ECG Device Gets FDA Clearance July 12, 2021 The handheld device enables healthcare professionals to measure their patients' QT intervals in 30 seconds. Read More
Foundation Medicine’s Lung Cancer Diagnostic Approved July 9, 2021 The tissue-based test can detect this type of cancer and identify patients who may be appropriate for treatment with Alunbrig. Read More
SeaSpine Gets 510(k) Clearance for Spinal Surgery Module July 9, 2021 The new application offers increased functionality for the company’s 7D Flash Navigation System. Read More
Siemens Healthineers Gets FDA 510(k) Clearance for Magnetic Resonance Scanner July 8, 2021 The scanner is wide enough to accommodate extremely obese and claustrophobic patients, the company said. Read More
China’s SonoScape Gains CE Mark for New Endoscope July 8, 2021 The EG-UC5T is the latest in the company’s ultrasound line launched in 2019. Read More
Hyalex Cartilage System Named Breakthrough Device July 8, 2021 The breakthrough devices program gives manufacturers additional opportunities for interacting with agency experts during premarket reviews. Read More
Via Surgical’s TissueTak Tendon Anchor Gets 510(k) Clearance July 7, 2021 The TissueTak system uses a suture-based anchor to attach a patch directly to the patient’s tendon. Read More
Feedback’s Bleepa Medical Imaging Communications App Gets UK Approval July 7, 2021 The app allows sharing and annotation of clinical-grade images on mobile devices. Read More
LumiraDx Gains CE Mark for COVID-19 Test July 7, 2021 The RNA test detects viral nucleic acid in 20 minutes or less on common polymerase chain reaction systems, the company said. Read More
Neuroelectrics’ Epilepsy Device Gets FDA Breakthrough Device Designation July 7, 2021 Patients in a pilot study experienced a 44 percent reduction in seizure frequency in the eight weeks post-treatment. Read More