Unusually antibiotic-resistant bacteria were recently identified by the CDC's Antibiotic Resistance Lab Network, according to a report issued by the agency last week. The Vital Signs report noted 220 occurrences in the U.S. of germs, also referred to as "nightmare bacteria," which could not be eradicated by the majority of or by any available antibiotics. Tru-d SmartUVC robot is intended to stifle the spread of antibiotic-resistant bacteria through UVC disinfection in patient rooms, and other hospital areas. A CDC-funded trial of the SmartUVC disinfection robot reduced the risk of acquiring or spreading four key "superbugs" by 30 percent.
Boston Scientific Corp. has acquired thermal monitoring system maker, Securus Medical Group Inc., for $40 million in cash and up to $10 million in regulatory and commercial milestones. Boston Scientific has invested in the private firm since 2016; the current price tag represents the remaining stake not owned by the company. Securus has developed an FDA-cleared infrared esophageal temperature monitor, which will become part of Boston Scientific's electrophysiology portfolio.
Abiomed Inc. won FDA PMA approval for its Impella CP heart pump with Smartassist and optical sensor, an update to its cardiac recovery portfolio. Clinical information gathered in testing of more than 60 technical specifications and data on engineering of the Impella Controller at two U.S. hospitals and among 38 patients led to the clearance. A temporary ventricular support device, Impella CP with Smartassist, will be marketed to select hospitals that meet designated heart recovery practices across the next fiscal year.
Pythagoras Medical received the CE mark for its minimally invasive Confidenht system designed to provide real-time guidance in finding hot spots to ablate in renal denervation (RDN) procedures used to treat patients with refractory hypertension. Confidenht also can confirm effective ablation and pinpoint patients who do not respond to ablative therapy.
Dexcom Inc. won an FDA de novo request for its Dexcom G6 continuous glucose monitoring (CGM) system, an upgrade from its prior G5 system, and one that eliminates the need for fingersticks. The device was approved for patients with diabetes as young as two years old, and can be used as a standalone system or with an automated insulin dosing (AID) system. Approval also means that the FDA has created standards and controls for CGM accuracy, clinical relevance, reliability, and study data requirements for CGM devices.
Medication adherence technology firm, Adherium Ltd., has won FDA approval for over-the-counter (OTC) sales of its Smartinhaler sensor for Astrazeneca's Symbicort asthma inhaler. The "jacket-like" device wraps the inhaler and records and shares data on use, timing and overall care plan management to a patient's smartphone and to their physician. While the company partners with the majority of inhaler developers to provide compatible sensor devices, the approval is Adherium's first in OTC.
Auris Health Inc. won FDA clearance for its minimally invasive, flexible and computer-assisted endoscopy platform aimed at extending the capabilities of endoscopy. The Monarch system is used to diagnose lung cancer by accessing small and difficult-to-reach peripheral nodules. Monarch is intended to increase precision, and eventually is planned to be used to treat such nodules.
