Medtronic plc’s Hugo robotic-assisted surgery system has received a CE mark for urologic and gynecologic procedures, paving the way for commercialization in Europe. The approval is a key milestone for the Dublin-headquartered company, following the launch of Hugo in Latin America and India. The company is prioritizing robotics as a major growth opportunity, but will face tough competition in the space as it goes head-to-head with established market leader Intuitive Surgical Inc. According to Medtronic, Europe could provide a significant opportunity due to its current low uptake of surgical robotic procedures.
Calpro AS and Ampersand Health Ltd. are combining technologies to provide a self-management and remote monitoring solution for people with inflammatory bowel disease (IBD). The partnership will integrate Oslo, Norway-based Calpro’s smart biomarker test with Ampersand’s digital therapeutic app My IBD Care. The companies said the collaboration could help reduce the administrative burden of IBD patient care.
Isoplexis Corp. has debuted on the Nasdaq, pricing its initial public offering of 8.3 million common shares at $15.00 per share. Shares of the proteomics platform developer (NASDAQ:ISO) were trading slightly under at $13 following the listing. The offering is expected to close on Oct. 12, 2021. The Branford, Conn.-based company is aiming to raise $125 million from the public market to accelerate commercialization of its cell analysis platforms. The single-cell proteomics systems are automated, benchtop products designed to reduce therapeutic development timelines.
Centogene NV and Twist Bioscience Corp. are linking up to develop custom assay kits for rare disease testing. The companies said the collaboration aims to make genetic tests more accessible to rare disease patients. Financial details were not disclosed. Centogene, which dubs itself the “rare disease company” is positioning to be a frontrunner in the testing market. The global rare disease genetic testing market size was valued at $812.3 million in 2019 and is projected to register a CAGR of 10.9% from 2020 to 2027.
Orthopedics device startup Amber Implants BV has received an FDA breakthrough designation for its cementless spinal implant Vcfix. The system is designed to treat vertebral compression fractures (VCFs), which can cause patients severe back pain and limited mobility. Currently, VCFs are treated with injection of bone cement into the vertebra.
It may be a small country, but Lithuania has lofty ambitions. The Baltic country is emerging as one of Europe’s rising life science stars, with annual growth of 22% and targeting 5% of its GDP to be generated by the life sciences sector in 2030. Export of medical devices has also doubled since 2008, with majority of the country’s production reaching the U.K., France, Russia, Spain and the U.S.
The FDA has granted clearance of Siemens Medical Solutions Inc.’s photon-counting computed tomography (CT) scanner, Naeotom Alpha. The new diagnostic imaging device uses a photon-counting detector that measures individual X-rays that pass through a patient's body, as opposed to current systems that use detectors that measure the total energy contained in X-rays at once. The scanner then transforms the information from the X-ray photons into a detailed three-dimensional image, which can be used by physicians to assist diagnosis or treatment preparation planning.
A cloud-based web application for long-term brain monitoring has received a CE mark to support personalized management of neuro-disorders such as epilepsy. Developed by Swiss neuroscience research organization Wyss Center, Epios Cloud displays and reviews electroencephalogram (EEG) recordings made by EEG devices using scalp and sub-scalp electrodes, heart rate and accelerometer measurements.
Activ Surgical Inc. has closed a $45 million series B financing round to kick off commercialization activities of its augmented reality surgical software suite. Founded in 2017, Boston-based Activ Surgical is preparing to commercialize its first product Activinsights, an FDA-cleared software that provides real-time, intraoperative visual data such as key blood flow identifiers to surgeons.
Glucomodicum Oy tapped contract manufacturer Phillips-Medisize LLC to develop its needle-free continuous glucose monitor (CGM), Talisman, which is based on Glucomodicum’s magnetohydrodynamic (MHD) platform technology that measures glucose levels from interstitial fluid. The wearable CGM – the size of a smartwatch – combines MHD technology with biosensors and algorithms so health care professionals can monitor patients’ diabetes.
