A previously announced offering to swap two Series W warrants for one Series Z warrant was extended by PAVmed to April 2. The Series W warrants can be exercised for one share of common stock at $5 each until Jan. 29, 2022, while the Series Z warrants can be exercised for one share at $3 per piece until April 30, 2024.
An agreement was reached by Apax Partners to buy Becton Dickinson's minority stake in its respiratory solutions joint venture, Vyaire Medical, for $435 million. The transaction, which is expected to be completed by the end of next month, will enable Vyaire to be directly controlled by Apax Funds.
Kernel Capital, the Bank of Ireland's venture capital fund, has invested nearly $1.7 million in Causeway Sensors, the medtech spinout of Queen's University. The company, which has made a sensor that enables real-time differentiation of various types of infections to reduce use of ineffective drugs, will use the money to support research and development.
Transparency Market Research predicts the worldwide market for spinal fusion devices will reach more than $10.97 billion by 2025 with a compound annual growth rate of 4.65%. Growth will be driven by the aging US population that is susceptible to degenerative spine disease and spine disorders, as well as people's desire to have an active lifestyle in old age.
Abbott was granted national reimbursement by Japan's Ministry of Health, Labor and Welfare for the MitraClip device effective April 1. The device was approved by the regulator last November for use in treating patients with severe degenerative mitral regurgitation and functional mitral regurgitation.
European regulators granted Trice Medical CE mark approval for its camera-equipped throwaway needle called mi-eye 2, which is designed for facilitating diagnosis of joint injuries. The device, which helps visualize the body's interior cavities in diagnostic and operative arthroscopic and endoscopic procedures, has also won approval from Health Canada.
Stakeholder input is being sought by the Saudi Food and Drug Authority for its two draft medtech guidelines, one of which compiles four International Medical Device Regulators Forum guidance documents on the regulation of software as a medical device. The other guideline, which focuses on medical device storage, handling and transportation, would help manufacturers and other establishments involved in distribution and importation activities to comply with the regulator's Medical Devices Interim Regulation.
Google's health care industry lead Cozi Namer recently told attendees at the FiercePharmaMarketing Forum that the key to creating seamless digital experiences is to remove friction by providing assistance and satisfying curiosity. "Magic should not happen by chance; it should be a function of engineering," Namer said.
The European Commission and the FDA approved CSL Behring's Hizentra human immune globulin as a maintenance therapy for patients with chronic inflammatory demyelinating polyneuropathy to prevent the relapse of neuromuscular disability and impairment.
The Cardiac Device Coordinated Registry Network, which would connect existing government and professional society registries of cardiac device data, was proposed by the FDA to enable procedure-based long-term follow-up for the devices, but it has drawn concerns from manufacturers and cardiologists. "Industry has to take its hands off the wheel, the FDA will have to accept a different standard of evidence and [the] CMS may need to change its quality standards for reimbursement," said Larry Wood, corporate vice president of transcatheter heart valves at Edwards Lifesciences.