Investors have injected $8.4 million into Swedish startup Sigrid Therapeutics AB to speed development of its oral medical device Sipore15. The technology is a tasteless and odorless white powder taken with water to reduce blood sugar levels in people at risk of developing diabetes.
Shares in Rewalk Robotics Ltd. are on the rise after the FDA awarded its Reboot exoskeleton device breakthrough device designation status. The wearable, battery-powered device is designed to assist individuals with lower limb disability due to stroke.
A new study has found that despite the risk, many patients are open to interventional procedures such as renal denervation (RDN) if it can lead to improved blood pressure. RDN is performed under local anesthetic and uses radio frequency ablation to burn the nerves in the renal arteries. The process causes a reduction in nerve activity, which decreases blood pressure.
Hot off the heels of a $45 million series B financing raise, Activ Surgical Inc. has completed the first clinical trial evaluating its Activinsights augment reality (AR)-based software suite and Activsight imaging module. The safety and feasibility study, carried out with The University of Texas Health Science Center at Houston (UTHealth Houston) is the first of several trials the Boston-based company is planning in 2021.
The FDA has granted Magstim Co. Ltd. 510(k) clearance for its transcranial magnetic stimulation (TMS) platform Horizon 3.0. TMS is a series of repetitive, focused magnetic pulses, used to stimulate brain cells. The noninvasive therapy has been touted as a cost-effective treatment for depression and is typically prescribed when antidepressants have failed, or the side effects are too disruptive to a patient’s lifestyle.
Astrazeneca plc has signed an agreement with liquid biopsy testing company Saga Diagnostics AB to develop dPCR assays. Lund, Sweden-based Saga Diagnostics will develop Sagasafe dPCR assays towards undisclosed methylated targets for analysis of tissue samples and liquid biopsies. The assay is part of Saga’s portfolio of “ultrasensitive technologies,” comprising Sagasign for personalized monitoring of cancer burden and minimal residual disease.
The FDA has granted a breakthrough device designation for Renovia Inc.’s digital therapeutic system Leva as a first-line treatment for chronic fecal incontinence (FI) in women. Fecal incontinence, also known as bowel leakage, is a progressive condition ranging from occasional leaks to a complete loss of bowel control. Common causes include diarrhea, constipation, and muscle or nerve damage that may be associated with aging or giving birth.
Tilak Healthcare SAS has received €7 million (US$8.08 million) from investors to push commercialization of its mobile game and vision monitoring platform, Odysight. The CE marked class I device is prescribed by ophthalmologists to remotely monitor age-related visual impairment and includes daily visual tests to stimulate cognitive and visual abilities. A rollout of the mobile game has already commenced in France.
Zap Surgical Systems Inc. is debuting its noninvasive brain tumor treatment to the European market through an agreement with Centre de Cancérologie de la Porte de Saint-Cloud (CCPSC). The Boulogne-based center, which is part of the American Hospital of Paris, said it expects patients to access the treatment by Fall 2022.
Alivecor Inc. is partnering with blockchain technology company Solve.Care to connect users of its Kardiamobile device to physicians through a telehealth network. Tallinn, Estonia-based Solve.Care’s blockchain platform, the Global Telehealth Exchange (GTHE), is an open global cross-border telehealth network currently available in 27 countries. Alivecor’s Kardiamobile 6L device is the first and only six-lead personal ECG cleared by the FDA. Through the partnership, Kardiamobile devices will be integrated with GTHE where physicians will be able to access a user’s electrocardiogram (ECG) reading upon their consent through teleconsultations.
