Showing all posts written by Steven Friedland
French medical device company BIOCORP announced in a press release that it received FDA 510(k) clearance for Mallya, a device that according to the company allows insulin pen injectors to capture and transmit injection data such as dose, date, and time of injection to a mobile app via Bluetooth.
According to the Mallya website, the device allows users to keep track of their doses as well as share dosage information with family members and medical professionals. BIOCORP offers three models of the Mallya, one for each type of disposable insulin pen. The device, shown below on a pen, comes in two pieces that clip on to the insulin pen and can be removed and reused with new pens.
On the recent FDA clearance, Eric Dessertenne, CEO of BIOCORP, commented:
This approval is a major achievement for BIOCORP and all of our employees who have been heavily involved in this regulatory process. This approval marks a historic achievement for BIOCORP as it allows the commercial launch of our Mallya device in the United States and illustrates BIOCORP’s ability to meet the highest regulatory requirements.
Other companies have also expressed interest in integrating insulin technology with Mallya. In March, Diabeloop, a company focused on artificial intelligence-driven insulin systems, announced a partnership with BIOCORP to integrate Mallya into Diabeloop’s automated insulin pumps.
The full BIOCORP press release can be found here.
A medical device patentee has asked the U.S. Supreme Court to save his design patent, related to an introducer sheath handle, from invalidity based on application of the “on-sale” bar, which prohibits patenting an invention if it has been for sale for over one year prior to the patent filing.
On July 6, 2022, in Junker v. Medical Components Inc., inventor Larry Junker filed a petition for certiorari asking the Supreme Court to review the Federal Circuit’s finding of invalidity of his design patent under the on-sale bar. Mr. Junker alleged that Medical Components, Inc. and Martech Medical Products, Inc. (collectively “MedComp”) infringed U.S. Design Patent No. D450,839 (the “D’839 patent”), entitled “Handle for Introducer Sheath.” An introducer sheath is a device used to place catheters. The D’839 patent covered the design of the introducer sheath’s handle with rounded “Mickey-Mouse-shaped ears” that made the device easier to grasp when inserting the catheter and when peeling apart and removing the sheath. Figure 1 from the D’389 patent is reproduced below:
Mr. Junker and MedComp filed cross-motions for summary judgment debating whether the D’839 patent was invalid under the “on-sale bar” of 35 U.S.C. § 102(b) (pre-AIA). Under 35 U.S.C. § 102(b) (pre-AIA), a patent claim is invalid if “the invention was . . . on sale in this country, more than one year prior to the date of the application for patent in the United States.” The parties disputed whether a 1999 letter regarding a price quotation, sent more than one year before the D’839 patent was filed, constituted a commercial offer for sale. The letter was sent by a third party manufacturer to Boston Scientific.
The district court concluded that the letter was not a commercial offer for sale and accordingly granted Mr. Junker’s motion for summary judgment of no invalidity. After a bench trial, the court awarded Mr. Junker $1.25 million in damages. On appeal, the U.S. Court of Appeals for the Federal Circuit disagreed, finding that the letter contained sufficient terms to constitute a commercial offer for sale rather than a mere quotation.
In his petition for certiorari, Mr. Junker urges the Supreme Court to review the Federal Circuit’s ruling, arguing that the Federal Circuit misapplied contract law because the 1999 letter was sent by a third party who had no right to sell the invention, and the letter expressly stated it was a quotation rather than a price list.
Mr. Junker’s petition for certiorari is available here.
The University of Washington announced that a team of researchers has developed a prothrombin time/international normalized ratio (PT/INR) blood clotting test that requires only a single drop of blood and a smartphone. According to the team’s February 11, 2022 paper published in Nature Communications, the test uses a tiny cup containing copper, and a blood clotting agent that is attached to the smartphone below the camera, as shown in the figure below from the paper.
After adding a drop of blood, the smartphone vibrates, causing the blood to react with copper and the agent to form a blood clot, all of which is observed and measured by the camera. A video of the device is here.
Blood clotting, also known as coagulation, is the process by which blood changes into a gel-like substance to prevent bleeding. Excessive blood clotting within blood vessels can restrict blood flow, leading to serious conditions like deep vein thrombosis and pulmonary embolisms. Blood thinners can reduce clotting, but patients must have their blood tested frequently to ensure proper dosage, as too much or too little blood clotting can be life-threatening.
Shyam Gollakota, a University of Washington professor and co-author of the paper, stated:
Back in the day, doctors used to manually rock tubes of blood back and forth to monitor how long it took a clot to form. This, however, requires a lot of blood, making it infeasible to use in home settings. The creative leap we make here is that we’re showing that by using the vibration motor on a smartphone, our algorithms can do the same thing, except with a single drop of blood. And we get accuracy similar to the best commercially available techniques. … This is the best of all worlds — it’s basically the holy grail of PT/INR testing. It makes it frugal and accessible to millions of people, even where resources are very limited.
Alpha Tau Medical Ltd. (“Alpha Tau”) is a medical technology start-up focused on the research, development, and commercialization of its Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) treatment for solid cancerous tumors. On October 8, 2021, Alpha Tau announced that it received FDA Breakthrough Device Designation for using Alpha DaRT to treat recurrent glioblastoma multiforme (GBM). GBM is an aggressive, often incurable form of cancer responsible for malignant brain tumors.
According to the FDA, the goal of its Breakthrough Devices Program is to “provide patients and health care providers with timely access to  medical devices by speeding up their development, assessment, and review.”
“As GBM is such a terrible disease, it is critical that we find new solutions for these patients, and we are thrilled that receipt of the FDA’s Breakthrough Device Designation will allow us to expedite our clinical collaborations with leading cancer centers in the U.S. and across the world, and to bring new hope for GBM patients. I am very proud of our team and our collaborators who have worked hard to extend the use of Alpha DaRT to GBM and have already accomplished so many amazing things. This is fantastic news for Alpha Tau and fantastic news for so many GBM patients around the world.”
Alpha DaRT works by first inserting a “seed” into a cancerous tumor. The seed then releases high-energy alpha particles that destroy the tumor while sparing the healthy tissue around it.
This is the second FDA Breakthrough Device Designation Alpha Tau has received. In June 2021, Alpha Tau announced the FDA’s designation of Alpha DaRT for treating squamous cell carcinoma, a type of skin cancer.