Conformis has secured a $20 million term loan and a $10 million credit revolver from Innovatus Capital Partners and East West Bank, as well as equity financing worth $3 million from Innovatus. The debt financing proceeds will be used for paying off a term loan with Oxford Finance.
A round of Series B financing involving Boston Scientific and other investors has brought in $15 million for startup InterVene, which makes the BlueLeaf Endovenous Valve Formation System for treating deep vein reflux. The company will use the proceeds for clinical research program expansion as well as for US trials via an investigative device exemption.
The FDA has granted Micro Medical Solutions investigative device exemption approval to conduct a 200-patient, randomized trial of MicroStent, a below-the-knee device intended for peripheral artery disease treatment. The company will begin enrollment in the trial immediately.
Co-Diagnostics has launched its Logix Smart ZDC multiplex assay, which is designed to detect chikungunya, dengue and Zika virus, at the recent conference of the Caribbean Public Health Agency. The test, which has CE mark approval, can be sold in Europe, Latin America and the Caribbean Basin.
Certain medical devices should be excluded from the list of potential goods that would be affected by the administration's proposed 25% tariff increase on Chinese goods, AdvaMed and medtech companies told the US Trade Representative in a hearing last week. "If tit-for-tat retaliation continues, the administration's objectives for a strong domestic medical technology industry will be undermined," said Ralph Ives, executive vice president of global strategy and analysis for AdvaMed.
A draft guidance on the clinical evidence needed for high-intensity ultrasound systems for prostate tissue ablation devices has been issued by the FDA, listing the type of data and clinical testing medtech companies must submit under the 510(k) pathway to comply with special controls. Data should demonstrate effectiveness and show the devices do not damage tissue outside the target area.
Lucid Diagnostics obtained 510(k) clearance from the FDA for its EsoCheck device, which can collect cells from a patient's esophagus in about five minutes without requiring an endoscopy.
Cali Botanicals and Kratom NC received warning letters from the FDA for selling unapproved kratom products with claims that they can treat opioid addiction and withdrawal symptoms.
The FDA has sent a warning letter to generic drugmaker Akorn related to an inspection of its manufacturing facility at Somerset, N.J., in July and August of last year. Akorn said it will address all issues cited in the letter and that production at the plant is expected to continue.