Swedish dosimetry company ScandiDos said yesterday it won FDA 510(k) clearance for its Delta4 Discover device designed to verify radiation doses delivered to patients during radiation treatments. The Delta4 Discover is designed as an in-vivo dosimetry system which independently verifies all dosage delivery parameters with the aim of increasing the quality and overall safety of radiation-based
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ScandiDos announced that Delta4 Discover received 510(k) clearance by the U.S. Food and Drug Administration, bringing to market the first device that independently verifies the radiation dose delivered to a patient during radiation treatment. “Until now, the concept of measuring the daily dose of radiation in real time, to ensure it accurately matches the patient
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ScandiDos announced today that Delta4 Discover received 510(k) clearance by the U.S. Food and Drug Administration, bringing to market the first device that independently verifies the radiation dose delivered to a patient during radiation treatment. Delta4 Discover is an in-vivo dosimetry system that provides tools for the measurement of the radiation dose delivered during cancer
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ScandiDos, a company in Quality Assurance (QA) and dosimetry for modern radiation therapy, unveils the world’s first and only Non-Extrapolated Radiation Accuracy Measurement system, Delta4 Synthesis and Express Measure, at the ASTRO Annual Meeting on September 25 to 27 at the Boston Convention and Exhibition Center. Delta4 Synthesis combines Delta4 Phantom+ and Delta4 Discover, FDA 510(k)
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Researchers have designed a new silicone-fabric sensor that can move with the human body and be used in wearables and robotics, according to research from Harvard University’s Wyss Institute for Biologically Inspired Engineering and the Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS). Typical sensors that are used on wearables like heart
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When designing and developing a medical device, companies often consider labeling down the road, but they shouldn’t, says Michael Drues, a regulatory consultant based outside Boston. Labeling can involve a variety of ways a medtech company markets a product. What Drues calls high-level labeling – indications for use, intended use and label claims – drives
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Fraunhofer researchers have created a tiny yet powerful diaphragm pump that can deliver ambient air to gas sensors. The sensors are attached to a smartphone that warns a user of heavy exposure to particulate matter. “Our smart pump measures only 25 sq mm, making it the world’s smallest pump. That said, it still has a
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Shares in Teleflex (NYSE:TFX) rose today after the medical device maker topped expectations on Wall Street with its 2nd quarter earnings results, providing lifted guidance for the rest of its fiscal year. The Wayne, Pa.-based company posted profits of $78 million, or $1.67 per share, on sales of $528.6 million for the 3 months ended June 30,
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Scientists have successfully edited genes in a human embryo, correcting a disease-causing mutation to prevent the defect from being inherited. The groundbreaking process, covered in a paper published yesterday in Nature, was confirmed last week by the Oregon Health and Science University, which collaborated with the Salk Institute and Korea’s Institute for Basic Science on
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Can you 3D print in water? According to researchers at the Hebrew University of Jerusalem’s Center for Nanoscience and Nanotechnology, you can. The Israeli researchers have developed a photoinitiator for 3D printing in water. 3D printing structures in water has always been challenging due to a lack of water soluble molecules known as photoinitiators —
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Qosina is touting the variety of Y connectors it stocks that are made from plastisol, a material used to make flexible components. Plastisol, also known as liquid polyvinyl chloride (PVC), offers great flexibility, according to Qosina. The material is Class VI approved and BPA- and latex-free. The Y connectors are made through dip molding rather than traditional injection
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By Stewart Eisenhart, Emergo Group China Food and Drug Administration (CFDA) regulators have addressed frequently asked questions regarding clinical trial requirements for medical devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its
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From MDCorp inking a European distribution deal to Align Technology’s North Carolina expansion, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. MDCorp inks distribution deal with Smart Endoscope Systems MDCorp announced in a July 31 press release that it has signed a distribution agreement with Smart Endoscope
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Peter Stebbins meets with a lot of medtech startups as medical device transactions lead at Johnson & Johnson Innovation in Boston. Often, they could benefit from a better grasp of what a buyer is looking for. “It’s not infrequent that someone with an idea perceives it should make sense to J&J, but they don’t understand where our
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Slug mucus is the inspiration behind a new adhesive to close surgical wounds and reduce the use of surgical staples, according to new research out of Harvard. Some of the current adhesives on the market can be toxic and stick together tissues weakly. Some can’t be used in wet environments altogether, which can pose a
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Designers in medical device and health industries can benefit from integrating 3D printing, machining and injection molding from prototyping to production and even during the post-launch phase of products. Todd Nelson, Proto Labs Using industrial 3D printing for rapid prototyping of parts for new medical devices and other products can mean design risk reduction for
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By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) have published further details on their plans to clarify and improve policies regarding mobile medical applications, wearables and other digital health products. Get the full story here at the Emergo Group’s blog. The
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Sterimed announced that it has bought a 70% stake in ATH Medical. Geoffrey Broninx, founder of ATH Medical, will have the remaining 30% stake in the company. The financial details of the deal were not disclosed. ATH Medical creates traceability solutions for healthcare centers. It is known for its WhiteReader and Ancitrak products that help
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Biostage (NSDQ:BSTG) touted today the first patient use of its Cellspan esophageal implant. The Holliston, Mass.-based company said that the regenerative implant was used in a 75-year old male patient, who has a life-threatening cancerous mass in his chest. Surgeons removed the portion of his esophagus affected by the cancer and Biostage’s implant was used to
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All companies begin with an idea. The details of protecting intellectual property, however, can be daunting, especially if your idea is in the field of medical technology. N. Scott Pierce and Alexander Adam, Hamilton, Brook, Smith & Reynolds PC Starting a medical device company requires a vast array of knowledge, including knowledge about almost every
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