Life Sciences
Top stories summarized by our editors
6/26/2019

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.

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Boston Scientific
6/26/2019

A funding round has brought in an undisclosed amount of proceeds for Fusion Robotics. The money will be used to pursue clearance for the company's spinal robotics platform and to launch the product.

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Becker's Spine Review
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Fusion Robotics
6/26/2019

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.

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MassDevice (Boston)
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Micro Medical Solutions, FDA
6/26/2019

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.

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Seeking Alpha
6/26/2019

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.

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Ralph Ives
6/26/2019

A draft guidance on the clinical evidence needed for high-intensity ultrasound systems for prostate tissue ablation devices has been issued by the FDA, listing the type of data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.

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FDA
6/26/2019

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.

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FDAnews
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Lucid Diagnostics, FDA, Lucid
6/26/2019

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.

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Reuters
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FDA
6/26/2019

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.

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Reuters
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Akorn, FDA
6/26/2019

The Chinese National Health Commission released a list that includes drugs with expired or close to expired patents and drugs that are scarce. Regulators are hoping that makers of generic drugs will respond by manufacturing some of the drugs on the list.

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Pharmafile (UK)