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Florida Man Makes Medical Device – A Survey of MedTech in the Sunshine State

Florida is more than just the home of alligators and presidential candidates. The state was recently ranked as the fourth largest “medical device state” in the U.S., after California, Minnesota, and Massachusetts.  It was...more

Left Atrial Appendage Occlusion Device Maker Conformal Medical Raises $35 Million in Oversubscribed Series D Round

On June 5, 2023, Conformal Medical Inc., developer of a left atrial appendage occlusion system, announced a successful Series D funding round, raising a total of $35 million. The round was led by SPRIG Equity with...more

Brain Computer Interface Developer Announces $33M Series A, Granted FDA “Breakthrough” Designation

Brain computer interface developer Paradromics on May 18, 2023, announced a $33 million Series A funding round as well as a “Breakthrough Device Designation” from the FDA....more

USPTO Issues Notice Regarding Patent Examinations and FDA Submissions

On July 29, 2022, the United States Patent and Trademark Office (USPTO) issued a Notice by Director Kathy Vidal that may be relevant to those seeking or holding patents on medical devices that require Food and Drug...more

Medical Device Cybersecurity Survey Report Released

Cybellum released a medical device survey report on April 20, 2022 entitled “Medical Device Cybersecurity: Trends and Predictions.” The company’s website states that their “mission is to enable manufacturers and their...more

Is your funded medical device startup actually a “large entity” according to the USPTO?

The U.S. Patent and Trademark Office (USPTO) allows a patent applicant to pay reduced fees if it qualifies as a “small entity.”  Many types of filing fees are reduced by 50%.  These savings can be important for companies on a...more

Strategies for Protecting Intellectual Property (IP) on a Reduced Budget

Shutdown orders due to the COVID-19 virus pandemic have created economic disruption, causing companies to scale back on intellectual property (IP) expense. This creates an opportunity to move ahead of the competition. This is...more

Trademarks Require “Use in Commerce” – But What If You Need Regulatory Approval Before Selling Your Medical Device?

The U.S. Patent and Trademark Office (USPTO) allows for a trademark application to be filed on an “Intent to Use” basis to establish a priority date before the mark is actually “used in commerce.” However, such use in...more

Trademarks Require “Use in Commerce” – But What If You Need Regulatory Approval Before Selling Your Product?

The U.S. Patent and Trademark Office (USPTO) allows for a trademark application to be filed on an “Intent to Use” basis to establish a priority date before the mark is actually “used in commerce.” However, such use in...more

FDA Issues Guidance on “Abbreviated” and “Special” 510(k) Pathways

The U.S. Food and Drug Administration (FDA) has issued two new guidance documents related respectively to an “abbreviated” and a “special” approach to the typical 510(K) process for medical devices....more

Boston Scientific Exercises Option to Acquire Transcatheter Annuloplasty Ring Developer Millipede Inc.

Global medical device company Boston Scientific has announced on December 27, 2018, that it exercised its option to acquire remaining shares of privately-held medical device company Millipede, Inc. upon its recent successful...more

Cook Medical Petitions for Inter Partes Review (IPR) of Medtronic “Jervis” Patent

On November 9, 2018, Cook Medical LLC filed a petition with the Patent Trial and Appeal Board requesting inter partes review (IPR) of U.S. Patent No. 6,306,141, assigned to Medtronic Vascular, Inc. The ‘141 Patent is...more

Medical Device Market Returns and Recent Industry Activity

The medical device and related markets have shown some growth recently. For example, IHI, an iShares U.S. Medical Devices ETF, has a total return of about 24% year-to-date in 2018. In the same time period, the S&P 500 has...more

Medical Device Connectivity Market Reported to Top $2.6 Billion by 2023

The market for medical device connectivity is projected to reach about $2.6 billion by the year 2023, according to a report published in April 2018 by several publishers. The report states that the connectivity market for...more

Boston Scientific Announces Agreement for Investment & Acquisition Option with Transcatheter Annuloplasty Ring Developer...

Global medical device company Boston Scientific has announced on January 24, 2018, an agreement to make a $90 million investment in privately-held medical device company Millipede, Inc. Millipede has developed a non-invasive...more

FDA Exempts Numerous Medical Devices from 510(k) Premarket Notification Requirements

The United States Food and Drug Administration (FDA) issued a Notice on July 11, 2017, exempting 1,003 Class II medical devices from premarket notification requirements under Section 510(k). The Notice indicates that anyone...more

FDA Issues Proposed Guidance for Changes to Medical Device Software

The U.S. Food & Drug Administration (FDA) issued a proposed guidance on August 8, 2016, regarding software changes to medical devices. The proposed guidance relates to requirements for submitting medical device software...more

Introduction to IP: Some Basics of Patents, Trademarks, & Trade Secrets

What is “Intellectual Property” (IP)? •Exclusive Rights to Certain Intellectual Products (Ideas) –Necessary due to the “non-rivalrous” nature of ideas: •“He who receives an idea from me, receives instruction...more

FDA Issues Draft Guidance for 3D Printed Medical Devices

The U.S. Food and Drug Administration (FDA) issued draft guidance for additive manufactured medical devices, more commonly known as 3D printed medical devices, on May 10, 2016. The draft guidance document, available here, is...more

Polymer for Celiac Disease is Confirmed as Class IIb Medical Device in European Union

According to a press release from the Israeli company BioLineRx, their novel polymer for treating Celiac Disease has been confirmed as a Class IIb medical device in the European Union (EU).  According to the company, the...more

7 Intellectual Property Issues Startup Entrepreneurs Should Not Overlook

When startups are in the whirlwind of launching a new product or strategizing a marketing plan, there are crucial intellectual property issues that should not be overlooked. Here are seven things startups should know about IP...more

FDA Announces 2016 Medical Device Fees

The Food and Drug Administration (FDA) recently issued a notice announcing the fiscal year (FY) 2016 medical device user fees, which apply to, among other things, applications for medical device approval. The National Law...more

Innovative Collaboration – IP Considerations

It is common for medical device makers to partner with doctors, universities, designers, manufacturers, R&D labs, or salespeople in the development of medical devices. To reap the intended benefits of such efforts,...more

Medical Device Trade Group Pens Letter in Opposition to Innovation Act

The Medical Device Manufacturers Association (“MDMA”) has been vocal in lobbying Capitol Hill for what they consider “necessary changes” to patent law for continuing medical device innovation.  Part of that lobbying has...more

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